Company ยท US
Oscor, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2021. Name variants (Inc, Corp, punctuation) are merged.
49510(k) clearances (0 in 12 months)
42recalls (3 in 12 months)
41recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DYB | Introducer, Catheter | 50 |
| DTB | Permanent Pacemaker Electrode | 21 |
| LDF | Electrode, Pacemaker, Temporary | 6 |
| DTD | Pacemaker Lead Adaptor | 4 |
| IKD | Cable, Electrode | 3 |
| DRC | Trocar | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| DQX | Wire, Guide, Catheter | 1 |
| DTE | Pulse-Generator, Pacemaker, External | 1 |
| DTG | Magnet, Test, Pacemaker | 1 |
| DYG | Catheter, Flow Directed | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 3, 2021 | K210627 | Breezeway II Oscor, Inc. | DYB |
| Sep 22, 2015 | K151951 | Destino Reach Oscor, Inc. | DYB |
| Mar 19, 2015 | K143463 | IS4/DF4 Port Plug Oscor, Inc. | DTD |
| Jul 9, 2014 | K140917 | INTRODUCER, MODEL ADELANTE MAGNUM Oscor, Inc. | DYB |
| Apr 17, 2014 | K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH Oscor, Inc. | DYB |
| Feb 13, 2014 | K130633 | INTRODUCER SETS, MODEL ADELANTE RADIAL Oscor, Inc. | DYB |
| Jan 8, 2014 | K130843 | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE Oscor, Inc. | DRC |
| Jun 13, 2013 | K130104 | GUIDEWIRE, PURSUER SERIES Oscor, Inc. | DQX |
| Dec 13, 2012 | K122960 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO Oscor, Inc. | DYB |
| Dec 13, 2012 | K122958 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY Oscor, Inc. | DYB |
| Aug 29, 2012 | K122084 | INTRODUCER SET, MODEL ADELANTE-S SERIES Oscor, Inc. | DYB |
| Jun 29, 2012 | K120459 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO Oscor, Inc. | DYB |
| Oct 20, 2010 | K101497 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY Oscor, Inc. | DYB |
| Jan 13, 2010 | K092118 | ANGIOGRAPHIC CATHETER, MODEL ANGIOS Oscor, Inc. | DQO |
| Jun 4, 2009 | K090114 | MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S Oscor, Inc. | DYB |
| Nov 14, 2008 | K081986 | SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE Oscor, Inc. | DRC |
| Jun 18, 2008 | K081052 | OCCLUSION BALLOON CATHETER, MODEL VENOS Oscor, Inc. | DYG |
| Jan 22, 2008 | K072770 | TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) Oscor, Inc. | LDF |
| Nov 30, 2007 | K073100 | INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S Oscor, Inc. | DYB |
| Jun 7, 2007 | K070926 | ELECTRODE/EXTENSION CABLES, MODELS ATAR Oscor, Inc. | IKD |
| Aug 6, 2004 | K041809 | PERMANENT PACING LEAD, MODEL PY2 Oscor, Inc. | DTB |
| Apr 7, 2004 | K040569 | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU Oscor, Inc. | DTB |
| Jun 19, 2003 | K031164 | PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV Oscor, Inc. | DTD |
| Jan 31, 2003 | K024053 | PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB Oscor, Inc. | DTB |
| Jan 14, 2003 | K024156 | PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR Oscor, Inc. | DTD |
| Mar 28, 2002 | K020669 | PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB Oscor, Inc. | DTB |
| Nov 8, 2001 | K013339 | PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS Oscor, Inc. | DTB |
| May 22, 2001 | K010787 | PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS Oscor, Inc. | DTD |
| May 22, 2001 | K003918 | OSCOR PERMANENT PACING LEAD RZ MODEL SERIES Oscor, Inc. | DTB |
| Mar 12, 1984 | K831926 | IMPLANTABLE ENDOCARDIAL PACING LEADS Oscor, Inc. | DTG |
| Dec 16, 1983 | K831768 | EXTERNAL PULSE GENERATOR FOR TEMP. STIM Oscor, Inc. | DTE |
| Oct 20, 1983 | K831997 | IMPLANTABLE ENDOCARDIAL PACING LEADS Oscor, Inc. | DTB |
| Oct 20, 1983 | K831804 | MULTIPOLAR TEMPORARY CARDIAC Oscor, Inc. | LDF |
| Oct 20, 1983 | K831751 | LEAD INTRODUCER SETS-EB-S8 & EB-S12 Oscor, Inc. | DYB |
| Oct 20, 1983 | K831695 | TEMP. CARDIAC PACING WIRE TME 60/61/65 Oscor, Inc. | LDF |
| Jul 26, 1983 | K831767 | IMPLANTABLE CARDIAC PACING LEADS Oscor, Inc. | DTB |
| Apr 30, 1983 | K823898 | MODEL MF..D & MX..D PACEMAKER LEADS Oscor, Inc. | DTB |
| Apr 30, 1983 | K823897 | MODEL SF. D&SX.D PACEMAKER LEADS Oscor, Inc. | DTB |
| Apr 30, 1983 | K823895 | MODEL RF. D&RX..D PACEMAKER LEADS Oscor, Inc. | DTB |
| Apr 30, 1983 | K823893 | MODEL MZ PACEMAKER LEAD-VARIOUS Oscor, Inc. | DTB |
| Apr 30, 1983 | K823889 | MODEL JY PACEMAKER LEAD - VARIOUS Oscor, Inc. | DTB |
| Apr 18, 1983 | K830950 | VASCULAR PRODUCTS IMPLANTABLE PACING Oscor, Inc. | DTB |
| Apr 18, 1983 | K830772 | TEMP. PACING LEAD, BIPOLAR #TH60, 90/110 Oscor, Inc. | LDF |
| Mar 31, 1983 | K823891 | MODEL KY PACEMAKER LEAD - VARIOUS Oscor, Inc. | DTB |
| Mar 31, 1983 | K823890 | MODEL ZY PACEMAKER LEAD-VARIOUS Oscor, Inc. | DTB |
| Dec 3, 1982 | K823448 | IMPLANTABLE PACING LEAD TINED #3390 & Oscor, Inc. | DTB |
| Dec 3, 1982 | K823446 | PRODUCTS IMPLANTABLE PACING LEAD,TINED Oscor, Inc. | DTB |
| Sep 19, 1979 | K791732 | IMPLANTABLE ENDOCARDIAL SCREW-IN ELEC Oscor, Inc. | DTB |
| Jun 4, 1979 | K782018 | LEADS, IMPLANTABLE CARDIAC PACEMAKERS Oscor, Inc. | DTB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2026 | Oscor Inc. Abiomed REF: 0052-3006, Introducer Kit for Impella
Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories. Open, Classified |
DYB | K122084 |
| Jul 10, 2026 | Oscor Inc. Abiomed REF: 0052-3021, Introducer Kit for Impella
Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories. Open, Classified |
DYB | K122084 |
| Jul 10, 2026 | Oscor Inc. Abiomed REF: 0052-3025, Introducer Kit for Impella
Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories. Open, Classified |
DYB | K122084 |
| Dec 22, 2021 | Oscor Inc. Destino Twist 14F (also branded as Guidestar 14F) Completed |
DYB | K140406 |
| Mar 10, 2021 | Oscor, Inc. AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters. Terminated |
DYB | None listed |
| Nov 8, 2018 | Oscor, Inc. 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 Terminated |
LDF | K861403 K884866 |
| Apr 10, 2017 | Oscor, Inc. 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 Terminated |
IKD | K070926 |
| Apr 10, 2017 | Oscor, Inc. 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 REUSAB Terminated |
IKD | K070926 |
| Oct 5, 2016 | Oscor, Inc. 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 Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 lef Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 lef Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 lef Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 le Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 lef Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 l Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 lef Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 punctu Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 p Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 p Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 punc Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 punct Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 punct Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 punct Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C120 S61CM
D66CM Catalog # AB101075
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punc Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C70 S61CM
D66CM Catalog # AB101073
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 10F C55 S61CM
D66CM Catalog # AB101072
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM
D84CM Catalog # AB081211
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal pu Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM
D66CM Catalog # AB081210
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal p Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C120 S79CM
D84CM Catalog # AB081047
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C90 S79CM D84CM Catalog # AB081046
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctur Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C70 S79CM D84CM Catalog # AB081045
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C55 S79CM D84CM Catalog # AB081044
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C120 S61CM
D66CM Catalog # AB081043
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C90 S61CM D66CM Catalog # AB081042
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. OSCOR ADELANTE BREEZEWAY 8F C70 S61CM D66CM Catalog # AB081041
Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu Terminated |
DYB | K101497 K122958 |
| Oct 5, 2016 | Oscor, Inc. 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 punctu Terminated |
DYB | K101497 K122958 |
| Oct 29, 2012 | Oscor, Inc. Myocardial Heart Wires
Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator. Terminated |
LDF | K831695 |
| Oct 29, 2008 | Oscor, Inc. Oscor Adelante Luer-Lock Peel Away Introducer Set, for introduction of diagnostic or therapeutic devices into the body. Terminated |
DYB | K073100 |
| Sep 24, 2008 | Oscor, Inc. 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 4 Terminated |
DTB | K010787 K040569 +2 |
| Jan 6, 2006 | Oscor Inc. Introducer Set. Labeled as ''Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)'' Catalog # 06607 (Oscor) and 666089-201 (Guidant) Terminated |
DYB | K871153 |