Oscor Inc.
Palm Harbor, FL, US
OSCOR INC. appears in FDA device records in Palm Harbor, FL. FDA records list 49 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 42 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 49 510(k) clearances for Oscor Inc. between 1979 and 2021. The busiest year on record is 1983, with 15. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 2 |
| 1982 | 2 |
| 1983 | 15 |
| 1984 | 1 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 2 |
| 2007 | 2 |
| 2008 | 3 |
| 2009 | 1 |
| 2010 | 2 |
| 2012 | 4 |
| 2013 | 1 |
| 2014 | 4 |
| 2015 | 2 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210627 | Breezeway II | DYB | Substantially Equivalent | |
| K151951 | Destino Reach | DYB | Substantially Equivalent | |
| K143463 | IS4/DF4 Port Plug | DTD | Substantially Equivalent | |
| K140917 | INTRODUCER, MODEL ADELANTE MAGNUM | DYB | Substantially Equivalent | |
| K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH | DYB | Substantially Equivalent | |
| K130633 | INTRODUCER SETS, MODEL ADELANTE RADIAL | DYB | Substantially Equivalent | |
| K130843 | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE | DRC | Substantially Equivalent | |
| K130104 | GUIDEWIRE, PURSUER SERIES | DQX | Substantially Equivalent | |
| K122960 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | DYB | Substantially Equivalent | |
| K122958 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | DYB | Substantially Equivalent | |
| K122084 | INTRODUCER SET, MODEL ADELANTE-S SERIES | DYB | Substantially Equivalent | |
| K120459 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | DYB | Substantially Equivalent | |
| K101497 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | DYB | Substantially Equivalent | |
| K092118 | ANGIOGRAPHIC CATHETER, MODEL ANGIOS | DQO | Substantially Equivalent | |
| K090114 | MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S | DYB | Substantially Equivalent | |
| K081986 | SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE | DRC | Substantially Equivalent | |
| K081052 | OCCLUSION BALLOON CATHETER, MODEL VENOS | DYG | Substantially Equivalent | |
| K072770 | TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) | LDF | Substantially Equivalent | |
| K073100 | INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S | DYB | Substantially Equivalent | |
| K070926 | ELECTRODE/EXTENSION CABLES, MODELS ATAR | IKD | Substantially Equivalent | |
| K041809 | PERMANENT PACING LEAD, MODEL PY2 | DTB | Substantially Equivalent | |
| K040569 | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU | DTB | Substantially Equivalent | |
| K031164 | PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV | DTD | Substantially Equivalent - Subject to Tracking Reg. | |
| K024053 | PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB | DTB | Substantially Equivalent | |
| K024156 | PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR | DTD | Substantially Equivalent | |
| K020669 | PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB | DTB | Substantially Equivalent | |
| K013339 | PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS | DTB | Substantially Equivalent - Subject to Tracking Reg. | |
| K010787 | PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS | DTD | Substantially Equivalent | |
| K003918 | OSCOR PERMANENT PACING LEAD RZ MODEL SERIES | DTB | Substantially Equivalent - Subject to Tracking Reg. | |
| K831926 | IMPLANTABLE ENDOCARDIAL PACING LEADS | DTG | Substantially Equivalent | |
| K831768 | EXTERNAL PULSE GENERATOR FOR TEMP. STIM | DTE | Substantially Equivalent | |
| K831997 | IMPLANTABLE ENDOCARDIAL PACING LEADS | DTB | Substantially Equivalent | |
| K831804 | MULTIPOLAR TEMPORARY CARDIAC | LDF | Substantially Equivalent | |
| K831751 | LEAD INTRODUCER SETS-EB-S8 & EB-S12 | DYB | Substantially Equivalent | |
| K831695 | TEMP. CARDIAC PACING WIRE TME 60/61/65 | LDF | Substantially Equivalent | |
| K831767 | IMPLANTABLE CARDIAC PACING LEADS | DTB | Substantially Equivalent | |
| K823898 | MODEL MF..D & MX..D PACEMAKER LEADS | DTB | Substantially Equivalent | |
| K823897 | MODEL SF. D&SX.D PACEMAKER LEADS | DTB | Substantially Equivalent | |
| K823895 | MODEL RF. D&RX..D PACEMAKER LEADS | DTB | Substantially Equivalent | |
| K823893 | MODEL MZ PACEMAKER LEAD-VARIOUS | DTB | Substantially Equivalent | |
| K823889 | MODEL JY PACEMAKER LEAD - VARIOUS | DTB | Substantially Equivalent | |
| K830950 | VASCULAR PRODUCTS IMPLANTABLE PACING | DTB | Substantially Equivalent | |
| K830772 | TEMP. PACING LEAD, BIPOLAR #TH60, 90/110 | LDF | Substantially Equivalent | |
| K823891 | MODEL KY PACEMAKER LEAD - VARIOUS | DTB | Substantially Equivalent | |
| K823890 | MODEL ZY PACEMAKER LEAD-VARIOUS | DTB | Substantially Equivalent | |
| K823448 | IMPLANTABLE PACING LEAD TINED #3390 & | DTB | Substantially Equivalent | |
| K823446 | PRODUCTS IMPLANTABLE PACING LEAD,TINED | DTB | Substantially Equivalent | |
| K791732 | IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC | DTB | Substantially Equivalent | |
| K782018 | LEADS, IMPLANTABLE CARDIAC PACEMAKERS | DTB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1035166 | 1035166 | OSCOR INC. | 4875 Palm Harbor Blvd, PALM HARBOR, FL 34683 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QBIAcute Coronary Syndrome Event Detector
- IKDCable, Electrode
- DYGCatheter, Flow Directed
- DQOCatheter, Intravascular, Diagnostic
- QJPCatheter, Percutaneous, Neurovasculature
- LDFElectrode, Pacemaker, Temporary
- PSRImplanted Phrenic Nerve Stimulator For Central Sleep Apnea
- DYBIntroducer, Catheter
- KYTLight, Examination, Medical, Battery Powered
- DTGMagnet, Test, Pacemaker
- DTDPacemaker Lead Adaptor
- DTBPermanent Pacemaker Electrode
- DTEPulse-Generator, Pacemaker, External
- QLKStimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)
- LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief
- DRCTrocar
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 42| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2680-2026 | Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories. | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. | Class I | Open, Classified | |
| Z-2679-2026 | Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories. | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. | Class I | Open, Classified | |
| Z-2678-2026 | Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories. | Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. | Class I | Open, Classified | |
| Z-0646-2022 | Destino Twist 14F (also branded as Guidestar 14F) | There is potential for separation between the threaded hub and threaded cap at the proximal end of the device. | Class II | Completed | |
| Z-1329-2021 | AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters. | Potential for open seal on sterile product | Class II | Terminated | |
| Z-0391-2019 | TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box. | During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. | Class I | Terminated | |
| Z-2733-2017 | ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker | The Reusable Oscor ATAR extension cables could separate from the connector during use. | Class I | Terminated | |
| Z-2340-2017 | ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker | The Reusable Oscor ATAR extension cables could separate from the connector during use. | Class I | Terminated | |
| Z-0819-2017 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0818-2017 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90 S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0817-2017 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90 S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0816-2017 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70 S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0815-2017 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S79CM D84CM GLOBAL Catalog # 990079-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0814-2017 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120 S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0813-2017 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90 S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0812-2017 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70 S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0811-2017 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55 S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0810-2017 | OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0809-2017 | OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0808-2017 | OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0807-2017 | OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0806-2017 | OSCOR ADELANTE BREEZEWAY 10F C120 S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0805-2017 | OSCOR ADELANTE BREEZEWAY 10F C90 S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0804-2017 | OSCOR ADELANTE BREEZEWAY 10F C70 S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated | |
| Z-0803-2017 | OSCOR ADELANTE BREEZEWAY 10F C55 S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain