Data / Medical devices / United States / Oscor Inc.
Oscor Inc.: FDA-registered device maker in Palm Harbor, FL, United States, 33 510(k) clearances and 1 PMA approval
Oscor Inc. is registered with the FDA (registration 1035166) in Palm Harbor, FL, United States. It lists 14 device types. The FDA files 33 510(k) clearances and 1 PMA approval under its listings, the newest dated December 17, 2021. 10 recall events name it as the recalling firm (3 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1035166
- Address
- 4875 Palm Harbor Blvd, Palm Harbor, FL, United States, 34683
- Owner or operator
- OSCOR INC. (1035166)
- Roles
- Complaint file establishment, Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler
- First device listed
- July 6, 1992
- Registered through
- 2026
- Brand names listed
- ATAR, Adelante, Adelante - S Series, Adelante Breezeway Delivery Sheath, Adelante Destino, Adelante Destino Steerable Guiding Sheath, Adelante Magnum, Adelante Radial and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 17, 2021 | K212340 | EMBOGUARD Balloon Guide Catheter | QJP | Substantially Equivalent | Neuravi Limited | accessdata.fda.gov |
| June 3, 2021 | K210627 | Breezeway II | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| September 22, 2015 | K151951 | Destino Reach | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| March 19, 2015 | K143463 | IS4/DF4 Port Plug | DTD | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| July 9, 2014 | K140917 | INTRODUCER, MODEL ADELANTE MAGNUM | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| April 17, 2014 | K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| February 13, 2014 | K130633 | INTRODUCER SETS, MODEL ADELANTE RADIAL | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| December 13, 2012 | K122960 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| December 13, 2012 | K122958 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| August 29, 2012 | K122084 | INTRODUCER SET, MODEL ADELANTE-S SERIES | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| June 29, 2012 | K120459 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| October 20, 2010 | K101497 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| January 13, 2010 | K092118 | ANGIOGRAPHIC CATHETER, MODEL ANGIOS | DQO | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| June 4, 2009 | K090114 | MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| June 18, 2008 | K081052 | OCCLUSION BALLOON CATHETER, MODEL VENOS | DYG | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| January 22, 2008 | K072770 | TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) | LDF | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| November 30, 2007 | K073100 | INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| June 7, 2007 | K070926 | ELECTRODE/EXTENSION CABLES, MODELS ATAR | IKD | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| August 6, 2004 | K041809 | PERMANENT PACING LEAD, MODEL PY2 | DTB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| April 7, 2004 | K040569 | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU | DTB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| June 19, 2003 | K031164 | PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV | DTD | Substantially Equivalent - Subject to Tracking Reg. | Oscor, Inc. | accessdata.fda.gov |
| January 31, 2003 | K024053 | PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB | DTB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| January 14, 2003 | K024156 | PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR | DTD | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| March 28, 2002 | K020669 | PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB | DTB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| May 22, 2001 | K010787 | PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS | DTD | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| May 3, 1994 | K925168 | MISCELLANEOUS PACING LEAD | DTD | Substantially Equivalent | Oscor Medical Corp. | accessdata.fda.gov |
| March 22, 1989 | K884866 | TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 | LDF | Substantially Equivalent | Oscor Medical Corp. | accessdata.fda.gov |
| December 3, 1987 | K872972 | TEMPORARY PACEMAKER ELECTRODE | LDF | Substantially Equivalent | Oscor Medical Corp. | accessdata.fda.gov |
| October 31, 1986 | K862966 | 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) | DTB | Substantially Equivalent | Oscor Medical Corp. | accessdata.fda.gov |
| June 27, 1986 | K861403 | TB SERIES BIPOLAR PACING LEADS | LDF | Substantially Equivalent | Oscor Medical Corp. | accessdata.fda.gov |
| April 10, 1985 | K850622 | OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR | LDF | Substantially Equivalent | Oscor Medical Corp. | accessdata.fda.gov |
| October 20, 1983 | K831695 | TEMP. CARDIAC PACING WIRE TME 60/61/65 | LDF | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| June 4, 1979 | K782018 | LEADS, IMPLANTABLE CARDIAC PACEMAKERS | DTB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 9, 2018 | P150009 | Guardian System | QBI | 12 | August 14, 2024 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 10, 2026 | 99102 | Class I | Ongoing | 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. | accessdata.fda.gov |
| December 22, 2021 | 89392 | Class II | Completed | 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. | accessdata.fda.gov |
| March 10, 2021 | 87562 | Class II | Terminated | 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 | accessdata.fda.gov |
| September 26, 2018 | 80984 | Class I | Terminated | 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 | 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. | accessdata.fda.gov |
| March 31, 2017 | 76884 | Class I | Terminated | 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, A | The Reusable Oscor ATAR extension cables could separate from the connector during use. | accessdata.fda.gov |
| October 5, 2016 | 75785 | Class II | Terminated | OSCOR ADELANTE BREEZEWAY 8F C55 S61CM D66CM Catalog # AB081040 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. | accessdata.fda.gov |
| July 25, 2012 | 63112 | Class II | Terminated | Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator. | Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification. | accessdata.fda.gov |
| July 3, 2008 | 49558 | Not yet classified | Terminated | Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body. | Difficulty breaking the sheath hub and subsequently to peel the sheath off for Introducer Set, Adelante size 7F. | accessdata.fda.gov |
| January 29, 2008 | 48678 | Not yet classified | Terminated | Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, REFINO 52RJU, REFINO 44RJU, REFINO48RJU, B | The O-rings are over tolerance making it hard to connect the leads to the pacemaker. | accessdata.fda.gov |
| September 13, 2005 | 34123 | Not yet classified | Terminated | Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)'' Catalog # 06607 (Oscor) and 666089-201 (Guidant) | Sheath size is larger than dilator size causing insertion difficulties. | accessdata.fda.gov |
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Updated July 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.