Cook Inc.
Bloomington, IN, US
COOK, INC. appears in FDA device records in Bloomington, IN. FDA records list 163 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 264 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 163FDA records hold 163 510(k) clearances for Cook Inc. between 1986 and 2015. The busiest year on record is 2013, with 12. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 7 |
| 1989 | 1 |
| 1990 | 9 |
| 1991 | 4 |
| 1992 | 7 |
| 1993 | 3 |
| 1994 | 6 |
| 1995 | 2 |
| 1996 | 4 |
| 1997 | 3 |
| 1998 | 6 |
| 1999 | 8 |
| 2000 | 5 |
| 2001 | 10 |
| 2002 | 7 |
| 2003 | 9 |
| 2004 | 8 |
| 2005 | 10 |
| 2006 | 3 |
| 2007 | 7 |
| 2008 | 5 |
| 2009 | 6 |
| 2010 | 6 |
| 2011 | 4 |
| 2012 | 2 |
| 2013 | 12 |
| 2014 | 5 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133130 | BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER | DQO | Substantially Equivalent | |
| K140593 | ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE | GCJ | Substantially Equivalent | |
| K132592 | FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET | DYB | Substantially Equivalent | |
| K133597 | CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY | JOH | Substantially Equivalent | |
| K131772 | CANTATA(R) 2.9 MICROCATHETER | KRA | Substantially Equivalent | |
| K131204 | ADVANCE CS CORONARY SINUS INFUSION CATHETER | DQY | Substantially Equivalent | |
| K133634 | SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET | LJS | Substantially Equivalent | |
| K132020 | ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K131201 | ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET | FGE | Substantially Equivalent | |
| K131206 | COOK CERVICAL RIPENING BALLOON | PFJ | Substantially Equivalent | |
| K132334 | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET | LJS | Substantially Equivalent | |
| K122091 | COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY | MPB | Unknown | |
| K130766 | ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE | DQX | Substantially Equivalent | |
| K122917 | CODA BALLOON CATHETER | DQY | Substantially Equivalent | |
| K130293 | ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER | LIT | Substantially Equivalent | |
| K130444 | H-30 HOLMIUM LASER SYSTEM | GEX | Substantially Equivalent | |
| K122940 | ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 | DQY | Substantially Equivalent | |
| K123707 | ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE | DQX | Substantially Equivalent | |
| K122937 | SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) | DQO | Substantially Equivalent | |
| K122796 | CXI SUPPORT CATHETER | KRA | Substantially Equivalent | |
| K113300 | ATB ADVANCE PTA DILATATION CATHETER | LIT | Substantially Equivalent | |
| K112185 | FOURSNARE VASCULAR RETRIEVAL SNARE | MMX | Substantially Equivalent | |
| K111244 | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) | LJS | Substantially Equivalent | |
| K110009 | ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE | DQX | Substantially Equivalent | |
| K101450 | CANTATA MICROCATHETER | KRA | Substantially Equivalent | |
| K101728 | FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE | BSP | Substantially Equivalent | |
| K101877 | OCCLUSION BALLOON CATHETER MODEL OBC | DQY | Substantially Equivalent | |
| K100283 | VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC | BTO | Substantially Equivalent | |
| K093209 | FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE | BSP | Substantially Equivalent | |
| K093469 | CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS | JOH | Substantially Equivalent | |
| K093052 | CROSSCATH SUPPORT CATHTER | KRA | Substantially Equivalent | |
| K091385 | APPROACH HYDRO ST WIRE GUIDE, MODEL HMW | DQX | Substantially Equivalent | |
| K091527 | ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER | DQY | Substantially Equivalent | |
| K090822 | ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER | DQY | Substantially Equivalent | |
| K090624 | COOK MREYE EMBOLIZATION COILS | KRD | Substantially Equivalent | |
| K090133 | CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS | FGE | Substantially Equivalent | |
| K080737 | MIRAFLEX HIGH FLOW MICROCATHETER | KRA | Substantially Equivalent | |
| K080037 | MODIFICATION TO ZILVER 635 BILIARY STENT | FGE | Unknown | |
| K081113 | COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS | FOZ | Substantially Equivalent | |
| K081690 | SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | |
| K073627 | FLEXOR EVAC ASPIRATION CATHETER | QEZ | Substantially Equivalent | |
| K073378 | ADVANCE 18LP PTA DILATATION CATHETER | DQY | Substantially Equivalent | |
| K072625 | TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) | LJS | Substantially Equivalent | |
| K072724 | CXI SUPPORT CATHETER | KRA | Substantially Equivalent | |
| K072240 | GUNTHER TULIP VENA CAVA FILTER | DTK | Substantially Equivalent | |
| K072148 | CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER | JOH | Substantially Equivalent | |
| K071640 | VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM | NHC | Substantially Equivalent | |
| K070410 | COOK MICROWIRE WIRE GUIDE | DQX | Substantially Equivalent | |
| K063619 | FLIPPER DETACHABLE EMBOLIZATION COILS | KRD | Substantially Equivalent | |
| K063252 | ATB ADVANCED PTA DILATATION CATHETER | DQY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012766489 | 3012766489 | COOK, INC. | 1700 N Curry Pike, Bloomington, IN 47404 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QEZAspiration Thrombectomy Catheter
- NGUBalloon, Liver Tamponade
- FCGBiopsy Needle
- EOQBronchoscope (Flexible Or Rigid)
- LITCatheter, Angioplasty, Peripheral, Transluminal
- PFJCatheter, Balloon, Dilation Of Cervical Canal Prior To Labor
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- KRACatheter, Continuous Flush
- DXECatheter, Embolectomy
- MSDCatheter, Hemodialysis, Implanted
- MPBCatheter, Hemodialysis, Non-Implanted
- MJNCatheter, Intravascular Occluding, Temporary
- DQOCatheter, Intravascular, Diagnostic
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- DQYCatheter, Percutaneous
- LFJCatheter, Subclavian
- NHCCatheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
- NDNCement, Bone, Vertebroplasty
- DWZDevice, Biopsy, Endomyocardial
- HCGDevice, Neurovascular Embolization
- MMXDevice, Percutaneous Retrieval
- KRDDevice, Vascular, For Promoting Embolization
- LQRDislodger, Stone, Biliary
- DTKFilter, Intravascular, Cardiovascular
- KNWInstrument, Biopsy
- KNAInstrument, Manual, Specialized Obstetric-Gynecologic
- GYKInstrument, Shunt System Implantation
- HAOInstrument, Surgical, Non-Powered
- DYBIntroducer, Catheter
- GCJLaparoscope, General & Plastic Surgery
- HETLaparoscope, Gynecologic (And Accessories)
- KPKMarker, Ostia, Aorto-Saphenous Vein
- FTLMesh, Surgical, Polymeric
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- BWCNeedle, Emergency Airway
- FMINeedle, Hypodermic, Single Lumen
- GEXPowered Laser Surgical Instrument
- ESWProsthesis, Esophageal
- JCTProsthesis, Tracheal, Expandable
- FPASet, Administration, Intravascular
- JXGShunt, Central Nervous System And Components
- FGEStents, Drains And Dilators For The Biliary Ducts
- IWJSystem, Applicator, Radionuclide, Manual
- JAQSystem, Applicator, Radionuclide, Remote-Controlled
- JOHTube Tracheostomy And Tube Cuff
- CBITube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
- BTOTube, Tracheostomy (W/Wo Connector)
- KNTTubes, Gastrointestinal (And Accessories)
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 264These records are listed because FDA’s enforcement report for the recall names this company, while the recall record itself carries the recalling firm under another name.
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0388-2022 | Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa | Class II | Terminated | |
| Z-0387-2022 | Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa | Class II | Terminated | |
| Z-0414-2022 | Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced visualization of needle tip when used with ultrasonic imaging equipment. | Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used. | Class II | Open, Classified | |
| Z-0223-2022 | Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxial set consisting of an outer catheter, curved-tip metal cannula, and a tapered-tip inner needle | Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death. | Class II | Terminated | |
| Z-0222-2022 | Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator. | Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges from increased procedural time to inflammatory reactions, which at their most severe include systemic reactions potentially leading to permanent impairment or death. | Class II | Terminated | |
| Z-0186-2022 | Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator. | Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time. | Class II | Terminated | |
| Z-0185-2022 | Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator. | Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time. | Class II | Terminated | |
| Z-0960-2021 | Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837 | Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation. | Class II | Terminated | |
| Z-0611-2021 | Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0610-2021 | Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0609-2021 | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0608-2021 | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0607-2021 | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0606-2021 | Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0605-2021 | Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0604-2021 | Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0603-2021 | Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0602-2021 | Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0601-2021 | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0600-2021 | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0599-2021 | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0598-2021 | Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0597-2021 | Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0596-2021 | Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated | |
| Z-0595-2021 | Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The potential adverse events that may occur include, but are not limited to increased procedural time, intervention to retrieve a separated segment, embolization occluding blood flow to a vital organ, vessel injury, and hemorrhage. | Class I | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Cook Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain