FDA 510(k) Applications Submitted by Oscor Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K143463 |
12/04/2014 |
IS4/DF4 Port Plug |
Oscor Inc. |
| K210627 |
03/02/2021 |
Breezeway II |
Oscor Inc. |
| K151951 |
07/15/2015 |
Destino Reach |
Oscor Inc. |
| K140917 |
04/10/2014 |
INTRODUCER, MODEL ADELANTE MAGNUM |
Oscor Inc. |
| K031164 |
04/14/2003 |
PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV |
Oscor Inc. |
| K130104 |
01/15/2013 |
GUIDEWIRE, PURSUER SERIES |
Oscor Inc. |
| K090114 |
01/21/2009 |
MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S |
Oscor Inc. |
| K120459 |
02/15/2012 |
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO |
Oscor Inc. |
| K020669 |
03/01/2002 |
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB |
Oscor Inc. |
| K040569 |
03/04/2004 |
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU |
Oscor Inc. |
| K130633 |
03/11/2013 |
INTRODUCER SETS, MODEL ADELANTE RADIAL |
Oscor Inc. |
| K010787 |
03/15/2001 |
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS |
Oscor Inc. |
| K130843 |
03/27/2013 |
SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE |
Oscor Inc. |
| K070926 |
04/03/2007 |
ELECTRODE/EXTENSION CABLES, MODELS ATAR |
Oscor Inc. |
| K081052 |
04/14/2008 |
OCCLUSION BALLOON CATHETER, MODEL VENOS |
Oscor Inc. |
| K101497 |
06/01/2010 |
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY |
Oscor Inc. |
| K041809 |
07/06/2004 |
PERMANENT PACING LEAD, MODEL PY2 |
Oscor Inc. |
| K081986 |
07/14/2008 |
SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE |
Oscor Inc. |
| K092118 |
07/14/2009 |
ANGIOGRAPHIC CATHETER, MODEL ANGIOS |
Oscor Inc. |
| K122084 |
07/16/2012 |
INTRODUCER SET, MODEL ADELANTE-S SERIES |
Oscor Inc. |
| K122958 |
09/25/2012 |
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY |
Oscor Inc. |
| K122960 |
09/25/2012 |
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO |
Oscor Inc. |
| K072770 |
09/28/2007 |
TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) |
Oscor Inc. |
| K013339 |
10/09/2001 |
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS |
Oscor Inc. |
| K073100 |
11/02/2007 |
INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S |
Oscor Inc. |
| K024053 |
12/09/2002 |
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB |
Oscor Inc. |
| K024156 |
12/17/2002 |
PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR |
Oscor Inc. |
| K003918 |
12/19/2000 |
OSCOR PERMANENT PACING LEAD RZ MODEL SERIES |
Oscor Inc. |
| K140406 |
02/18/2014 |
DESTINO TWIST, STEERABLE GUIDING SHEATH |
Oscor Inc. |
|
|
