Cerenovus, Inc.
Raynham, MA, US
Cerenovus, Inc. appears in FDA device records in Raynham, MA. FDA records list 163 510(k) clearances between and , 37 PMA records and 3 registered establishments. As of , FDA records show 79 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Cerenovus, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Codman and Shurtleff, Inc.510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 163FDA records hold 163 510(k) clearances for Cerenovus, Inc. between 1976 and 2026. The busiest year on record is 1976, with 15. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 15 |
| 1977 | 3 |
| 1978 | 4 |
| 1979 | 5 |
| 1980 | 2 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 6 |
| 1985 | 6 |
| 1986 | 3 |
| 1987 | 4 |
| 1988 | 4 |
| 1989 | 3 |
| 1990 | 6 |
| 1991 | 10 |
| 1992 | 3 |
| 1993 | 9 |
| 1994 | 3 |
| 1995 | 2 |
| 1996 | 1 |
| 1999 | 1 |
| 2000 | 3 |
| 2001 | 3 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 4 |
| 2007 | 3 |
| 2008 | 1 |
| 2009 | 5 |
| 2010 | 3 |
| 2011 | 4 |
| 2012 | 6 |
| 2013 | 2 |
| 2014 | 4 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 7 |
| 2019 | 1 |
| 2020 | 1 |
| 2023 | 3 |
| 2024 | 4 |
| 2025 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262419 | MICRUSFRAME (MFR100202); MICRUSFRAME (MFR100253); MICRUSFRAME (MFR100305); MICRUSFRAME (MFR100356); MICRUSFRAME (MFR100407); MICRUSFRAME (MFR100412); MICRUSFRAME (MFR100509); MICRUSFRAME (MFR100517); MICRUSFRAME (MFR100611); MICRUSFRAME (MFR100626); MICRUSFRAME (MFR100713); MICRUSFRAME (MFR100730); MICRUSFRAME (MFR100816); MICRUSFRAME (MFR100829); MICRUSFRAME (MFR140225); MICRUSFRAME (MFR140303); MICRUSFRAME (MFR140304); MICRUSFRAME (MFR140306); MICRUSFRAME (MFR140406); MICRUSFRAME (MF | HCG | Substantially Equivalent | |
| K262398 | CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set | NRY | Substantially Equivalent | |
| K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set | NRY | Substantially Equivalent | |
| K241244 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter | QJP | Substantially Equivalent | |
| K241221 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing Set | NRY | Substantially Equivalent | |
| K233982 | CEREGLIDE 92 Catheter System | QJP | Substantially Equivalent | |
| K233988 | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing Set | NRY | Substantially Equivalent | |
| K230726 | CEREGLIDE 92 Intermediate Catheter | QJP | Substantially Equivalent | |
| K221934 | CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set | NRY | Substantially Equivalent | |
| K221930 | CEREGLIDE 71 Intermediate Catheter | QJP | Substantially Equivalent | |
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set | NRY | Substantially Equivalent | |
| K191237 | CERENOVUS Large Bore Catheter | DQY | Substantially Equivalent | |
| K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit | GWM | Substantially Equivalent | |
| K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag | JXG | Substantially Equivalent | |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) | JXG | Substantially Equivalent | |
| K171862 | GALAXY G3 Mini Microcoil Delivery System | HCG | Substantially Equivalent | |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System | HCG | Substantially Equivalent | |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up | DQY | Substantially Equivalent | |
| K162563 | YOGA Microcatheter | DQY | Substantially Equivalent | |
| K162437 | Codman EDS3 CSF External Drainage System | JXG | Substantially Equivalent | |
| K153347 | Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit | GWM | Substantially Equivalent | |
| K152481 | DURAFORM Dural Graft Implant | GXQ | Substantially Equivalent | |
| K150319 | MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS | HCG | Substantially Equivalent | |
| K142429 | CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable | HCG | Substantially Equivalent | |
| K140080 | ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB | DQY | Substantially Equivalent | |
| K140307 | ENVOY GUIDING CATHETER | DQY | Substantially Equivalent | |
| K133625 | AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & | MOF | Substantially Equivalent | |
| K132281 | ReVive PV (Peripheral Vasculature) Thrombectomy Device | QEW | Substantially Equivalent | |
| K123560 | VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM | HCG | Substantially Equivalent | |
| K121776 | AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE | DQX | Substantially Equivalent | |
| K122118 | HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM | JXG | Substantially Equivalent | |
| K120117 | CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM | KCT | Substantially Equivalent | |
| K120686 | ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM | HCG | Substantially Equivalent | |
| K120274 | DELTAMAXX 18 MICROCOIL SYSTEM | HCG | Substantially Equivalent | |
| K120229 | ENVOY DISTAL ACCESS GUIDING CATHETER | DQY | Substantially Equivalent | |
| K112828 | REVIVE INTERMEDIATE CATHETER (REVIVE IC) | DQY | Substantially Equivalent | |
| K110751 | CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER | JXG | Substantially Equivalent | |
| K102961 | HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM | JXG | Substantially Equivalent | |
| K102589 | CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER | JXG | Substantially Equivalent | |
| K093973 | TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | HCG | Substantially Equivalent | |
| K092437 | CODMAN STERILIZATION CONTAINERS | KCT | Substantially Equivalent | |
| K100351 | NEUROSCOUT STEERABLE GUIDEWIRE | DQX | Substantially Equivalent | |
| K093184 | ENVOY GUIDING CATHETERS | DQY | Substantially Equivalent | |
| K091921 | CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP | HCH | Substantially Equivalent | |
| K083895 | CODMAN ISOCOOL BIPOLAR FORCEPS | GEI | Substantially Equivalent | |
| K091346 | CODMAN HAKIM MICRO II VALVE | JXG | Substantially Equivalent | |
| K090348 | CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET | JXG | Substantially Equivalent | |
| K073336 | CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 | HBF | Substantially Equivalent | |
| K071931 | CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 | HBF | Substantially Equivalent | |
| K071791 | MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 | GXP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1226348 | 3002947440 | Cerenovus, Inc. | 325 Paramount Drive, RAYNHAM, MA 02767 US | 2026 | |
| 3007628272 | 3007628272 | Cerenovus, Inc. | 6303 Waterford District Drive, Miami, FL 33126 US | 2026 | and 4 more, listed in full below |
| 3008264254 | 3008264254 | Cerenovus, Inc. | Calle Circuito Interior Norte #1820, Ciudad Juarez, Chihuahua Mexico C.P. 32574 MX | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DRRAmplifier And Signal Conditioner, Biopotential
- GWBAntisera, Fluorescent, All Types, Streptococcus Pneumoniae
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- KWPAppliance, Fixation, Spinal Interlaminal
- HCIApplier, Aneurysm Clip
- HRXArthroscope
- ITYAssembly, Tube Housing, X-Ray, Diagnostic
- DWHBlade, Saw, Surgical, Cardiovascular
- KRACatheter, Continuous Flush
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- HCACatheter, Ventricular
- JDQCerclage, Fixation
- HOXChart, Visual Acuity
- HCEClamp, Carotid Artery
- HCHClip, Aneurysm
- HBOClip, Scalp
- HHKCurette, Suction, Endometrial (And Accessories)
- GWMDevice, Monitoring, Intracranial Pressure
- HCGDevice, Neurovascular Embolization
- KRDDevice, Vascular, For Promoting Embolization
- HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)
- GXQDura Substitute
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GCQEndoscope, Flexible
- GWGEndoscope, Neurological
- HBMHeadrest, Neurosurgical
- HBLHolder, Head, Neurosurgical (Skull Clamp)
- HTZInstrument, Cutting, Orthopedic
- GYKInstrument, Shunt System Implantation
- HAOInstrument, Surgical, Non-Powered
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- DWSInstruments, Surgical, Cardiovascular
- HMYKeratome, Battery-Powered
- HNNKnife, Ophthalmic
- GCJLaparoscope, General & Plastic Surgery
- KMJLubricant, Patient
- JXHMethyl Methacrylate For Aneurysmorrhaphy
- GXPMethyl Methacrylate For Cranioplasty
- HAWNeurological Stereotaxic Instrument
- HBANeurosurgical Paddie
- HLJOphthalmoscope, Battery-Powered
- JEYPlate, Bone
- GEXPowered Laser Surgical Instrument
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- GADRetractor
- GZTRetractor, Self-Retaining, For Neurosurgery
- HPCSet, Lens, Trial, Ophthalmic
- JXGShunt, Central Nervous System And Components
- KPMShunt, Peritoneal
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- GXOStrip, Craniosynostosis, Preformed
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- KGGTissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations
- HAXTong, Skull For Traction
- ITXTransducer, Ultrasonic, Diagnostic
- HRHTrephine, Manual, Ophthalmic
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 79| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0434-2026 | CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM 3.5MM X 6.6 CM/FCX100356, UNIFORM 4MM X 7.5 CM/FCX100407, UNIFORM 4MM X 11.5 CM/FCX100412, UNIFORM 5MM X 9.7 CM/FCX100509, UNIFORM 5MM X 17 CM/FCX100517, UNIFORM 6MM X 11.9 CM/FCX100611, UNIFORM 6MM X 26 CM/FCX100626, UNIFORM 7MM X 13.9 CM/FCX100713, UNIFORM 7MM X 30 CM/FCX100730, UNIFORM 8MM X 16.1 CM/FCX100816, UNIFORM 8MM X 29 CM/FCX100829, UNIFORM 3D 2MM X 2.5 CM/FCX140225, UNIFORM 3D 3MM X 3 CM/FCX140303, UNIFORM 3D 3MM X 4 CM/FCX140304, UNIFORM 3D 3MM X 6 CM/FCX140306, UNIFORM 3D 4MM X 6 CM/FCX140406, UNIFORM 3D 4MM X 8 CM/FCX140408, UNIFORM 3D 4MM X 4.5 CM/FCX140445, UNIFORM 3D 5MM X 7 CM/FCX140507, UNIFORM 3D 5MM X 12 CM/FCX140512, UNIFORM 3D 6MM X 9 CM/FCX140609, UNIFORM 3D 6MM X 15 CM/FCX140615, UNIFORM 3D 7MM X 11 CM/FCX140711, UNIFORM 3D 7MM X 17 CM/FCX140717, UNIFORM 3D 8MM X 12 CM/FCX140812, UNIFORM 3D 8MM X 20 CM/FCX140820, UNIFORM 3D 9MM X 14 CM/FCX140914, UNIFORM 3D 9MM X 22 CM/FCX140922, UNIFORM 3D 10MM X 16 CM/FCX141016, UNIFORM 3D 10MM X 25 CM/FCX141025, UNIFORM 3D 11MM X 18 CM/FCX141118, UNIFORM 3D 11MM X 27 CM/FCX141127, UNIFORM 3D 12MM X 19 CM/FCX141219, UNIFORM 3D 12MM X 30 CM/FCX141230, UNIFORM XL 5MM X 10 CM/FCX180510, UNIFORM XL 6MM X 12.2 CM/FCX180612, UNIFORM XL 7MM X 14.3 CM/FCX180714, UNIFORM XL 8MM X 13.6 CM/FCX180813, UNIFORM XL 8MM X 30 CM/FCX180830, UNIFORM XL 9MM X 15.3 CM/FCX180915, UNIFORM XL 9MM X 33 CM/FCX180933, UNIFORM XL 10MM X 17.1 CM/FCX181017, UNIFORM XL 10MM X 34 CM/FCX181034, UNIFORM XL 11MM X 18.9 CM/FCX181118, UNIFORM XL 11MM X 37 CM/FCX181137, UNIFORM XL 12MM X 20.7 CM/FCX181220, UNIFORM XL 12MM X 40 CM/FCX181240, UNIFORM XL 13MM X 43 CM/FCX181343, UNIFORM XL 14MM X 47 CM/FCX181447, UNIFORM XL 15MM X 50 CM/FCX181550, UNIFORM XL 16MM X 47 CM/FCX181647, UNIFORM XL 17MM X 50 CM/FCX181750, UNIFORM XL 18MM X 46 CM/FCX181846, UNIFORM XL 19MM X 50 CM/FCX181950, UNIFORM XL 20MM X 50 CM/FCX182050, FREEFORM MINI 1MM X 1CM/MCR091010, FREEFORM MINI 1MM X 1.5CM/MCR091015, FREEFORM MINI 1MM X 2CM/MCR091020, FREEFORM MINI 1MM X 2.5CM/MCR091025, FREEFORM MINI 1MM X 3CM/MCR091030, FREEFORM MINI 1MM X 4CM/MCR091040, FREEFORM MINI 1.5MM X 2CM/MCR091520, FREEFORM MINI 1.5MM X 2.5CM/MCR091525, FREEFORM MINI 1.5MM X 3CM/MCR091530, FREEFORM MINI 1.5MM X 4CM/MCR091540, FREEFORM MINI 2MM X 2CM/MCR092020, FREEFORM MINI 2MM X 3CM/MCR092030, FREEFORM MINI 2MM X 4CM/MCR092040, FREEFORM MINI 2MM X 6CM/MCR092060, FREEFORM MINI 2.5MM X 3.5CM/MCR092535, FREEFORM MINI 2.5MM X 4.5CM/MCR092545, FREEFORM MINI 2.5MM X 5.5CM/MCR092555, FREEFORM MINI 3MM X 4CM/MCR093040, FREEFORM MINI 3MM X 6CM/MCR093060, FREEFORM MINI 3MM X 8CM/MCR093080, FREEFORM 2MM X 2 CM/SCR120202, FREEFORM 3MM X 6 CM/SCR120306, FREEFORM 3MM X 8 CM/SCR120308, FREEFORM 4MM X 7 CM/SCR120407, FREEFORM 4MM X 10 CM/SCR120410, FREEFORM 4MM X 12 CM/SCR120412, FREEFORM 5MM X 10 CM/SCR120510, FREEFORM 5MM X 15 CM/SCR120515, FREEFORM 6MM X 10 CM/SCR120610, FREEFORM 6MM X 15 CM/SCR120615, FREEFORM 6MM X 20 CM/SCR120620, FREEFORM 7MM X 15 CM/SCR120715, FREEFORM 7MM X 21 CM/SCR120721, FREEFORM 8MM X 15 CM/SCR120815, FREEFORM 8MM X 24 CM/SCR120824, FREEFORM 9MM X 25 CM/SCR120925, FREEFORM 10MM X 30 CM/SCR121030, FREEFORM 12MM X 30 CM/SCR121230, FREEFORM 2.5MM X 5 CM/SCR122505, FREEFORM 2.5MM X 3.5 CM/SCR122535, FREEFORM 3.5MM X 9 CM/SCR123509, FREEFORM 3.5MM X 7.5 CM/SCR123575, HELIFORM SOFT 1.5MM X 4 CM/SHD100154, HELIFORM SOFT 2MM X 8 CM/SHD100208, HELIFORM SOFT 2.5MM X 10 CM/SHD100250, HELIFORM SOFT 2.5MM X 8 CM/SHD100258, HELIFORM SOFT 3MM X 8 CM/SHD100308, HELIFORM SOFT 3MM X 10 CM/SHD100310, HELIFORM SOFT 4MM X 8 CM/SHD100408, HELIFORM SOFT 4MM X 10 CM/ SHD100410, HELIFORM SOFT 5MM X 10 CM/ SHD100510, HELIFORM SOFT 5MM X 15 CM/ SHD100515, HELIFORM SOFT 6MM X 12 CM/ SHD100612, HELIFORM SOFT 6MM X 16 CM/ SHD100616, HELIFORM SOFT 7MM X 16 CM/ SHD100716, HELIFORM SOFT 7MM X 20 CM/ SHD100720, HELIFORM SOFT 8MM | Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention. | Class I | Open, Classified | |
| Z-2280-2019 | GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm). | Incorrect coil length on the label | Class II | Terminated | |
| Z-1572-2014 | MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. | A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life. | Class II | Terminated | |
| Z-1571-2014 | MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. | A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life. | Class II | Terminated | |
| Z-1684-2015 | CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calibrated Syringe Barrel, Tubing Set and Stopcock for pump refills. . | Needle is leaking from hub/needle cannula connection | Class II | Terminated | |
| Z-0091-2015 | Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated | tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus) | Class II | Terminated | |
| Z-0090-2015 | Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated | tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus) | Class II | Terminated | |
| Z-0089-2015 | Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated | tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus) | Class II | Terminated | |
| Z-2191-2014 | Codman Certas - In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8807 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). | Class II | Terminated | |
| Z-2190-2014 | Codman Certas - In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). | Class II | Terminated | |
| Z-2189-2014 | Codman Certas - In Line Valve with SIPHONGUARD Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). | Class II | Terminated | |
| Z-2188-2014 | Codman Certas - In Line Valve only with SIPHONGUARD Device; Product Code: 82-8804 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). | Class II | Terminated | |
| Z-2187-2014 | Codman Certas - In line Valve with Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8803 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). | Class II | Terminated | |
| Z-2186-2014 | Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). | Class II | Terminated | |
| Z-2185-2014 | Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). | Class II | Terminated | |
| Z-2184-2014 | Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. | To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU). | Class II | Terminated | |
| Z-1468-2014 | CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories 82-8804 In Line Valve only with SIPHONGUARD Device 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories 82-8850 Certas Therapeutic Management System | Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves. | Class II | Terminated | |
| Z-0789-2014 | TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery. | Incorrect instructions for use (IFU). | Class I | Terminated | |
| Z-0788-2014 | TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. | Incorrect instructions for use (IFU). | Class I | Terminated | |
| Z-2300-2013 | MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. | Drug flow rates exceeding programmed flow rates. | Class I | Terminated | |
| Z-2299-2013 | MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. | Drug flow rates exceeding programmed flow rates. | Class I | Terminated | |
| Z-2298-2013 | MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. | Drug flow rates exceeding programmed flow rates. | Class I | Terminated | |
| Z-2297-2013 | MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. | Drug flow rates exceeding programmed flow rates. | Class I | Terminated | |
| Z-2296-2013 | MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. | Drug flow rates exceeding programmed flow rates. | Class I | Terminated | |
| Z-2295-2013 | MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. | Drug flow rates exceeding programmed flow rates. | Class I | Terminated |
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