Breezeway II
Oscor Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1035166 | 1035166 | OSCOR INC. | 1 | N | 2026-01-01 | 4875 Palm Harbor Blvd PALM HARBOR FL US 34683 |
| 3004785273 | 3004785273 | OSCOR CARIBE LLC | 1 | N | 2026-01-01 | ZONA FRANCA LAS AMERICAS NAVE A1-2 SANTO DOMINGO Distrito Nacional DO -- |
| 3014015536 | 3014015536 | OSCOR INC. | 1 | N | 2020-04-25 | 4614 Pet Lane, Unit 109 -- Lutz FL US 33559 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10836559006210 | ATAR D-A - Disposable Extension Cable | +1(727)937-2511 | sales@oscor.com |
| 10836559006227 | ATAR D-AT - Disposable Extension Cable | +1(727)937-2511 | sales@oscor.com |
| 10836559006234 | ATAR D-MDT - Disposable Extension Cable | +1(727)937-2511 | sales@oscor.com |
| 10836559006241 | ATAR D-T - Disposable Extension Cable | +1(727)937-2511 | sales@oscor.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 211522 | 1152773835 | P160039 | remede® System | PSR | 2017-10-06 |
| 28406 | 1889872063 | P150009 | Guardian System | QBI | 2018-04-09 |
| 28406 | 1058218311 | P130019 | MAESTRO RECHARGEABLE SYSTEM | PIM | 2015-01-14 |
| 211522 | 1058218311 | P130019 | MAESTRO RECHARGEABLE SYSTEM | PIM | 2015-01-14 |
| 28406 | 1269283234 | P110042 | SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM | LWS | 2012-09-28 |
| 211522 | 1269283234 | P110042 | SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM | LWS | 2012-09-28 |
| 28406 | 1799965543 | K925168 | MISCELLANEOUS PACING LEAD | DTD | 1994-05-03 |
| 211522 | 1799965543 | K925168 | MISCELLANEOUS PACING LEAD | DTD | 1994-05-03 |
| 23563 | 2026175434 | K925168 | MISCELLANEOUS PACING LEAD | DTD | 1994-05-03 |
| 28406 | 1785567023 | K884866 | TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 | LDF | 1989-03-22 |
| 211522 | 1785567023 | K884866 | TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 | LDF | 1989-03-22 |
| 23563 | 1837998472 | K884866 | TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 | LDF | 1989-03-22 |
| 28406 | 1015334401 | K872972 | TEMPORARY PACEMAKER ELECTRODE | LDF | 1987-12-03 |
| 211522 | 1015334401 | K872972 | TEMPORARY PACEMAKER ELECTRODE | LDF | 1987-12-03 |
| 23563 | 1027795786 | K872972 | TEMPORARY PACEMAKER ELECTRODE | LDF | 1987-12-03 |
| 28406 | 1552407748 | K862966 | 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) | DTB | 1986-10-31 |
| 211522 | 1552407748 | K862966 | 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) | DTB | 1986-10-31 |
| 23563 | 1044484743 | K861403 | TB SERIES BIPOLAR PACING LEADS | LDF | 1986-06-27 |
| 28406 | 1183573332 | K861403 | TB SERIES BIPOLAR PACING LEADS | LDF | 1986-06-27 |
| 211522 | 1183573332 | K861403 | TB SERIES BIPOLAR PACING LEADS | LDF | 1986-06-27 |
| 23563 | 1050135649 | K850622 | OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR | LDF | 1985-04-10 |
| 28406 | 1889381332 | K850622 | OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR | LDF | 1985-04-10 |
| 211522 | 1889381332 | K850622 | OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR | LDF | 1985-04-10 |
| 28406 | 1055641859 | K831695 | TEMP. CARDIAC PACING WIRE TME 60/61/65 | LDF | 1983-10-20 |
| 211522 | 1055641859 | K831695 | TEMP. CARDIAC PACING WIRE TME 60/61/65 | LDF | 1983-10-20 |
| 23563 | 1723645182 | K831695 | TEMP. CARDIAC PACING WIRE TME 60/61/65 | LDF | 1983-10-20 |
| 23563 | 1445382572 | K782018 | LEADS, IMPLANTABLE CARDIAC PACEMAKERS | DTB | 1979-06-04 |
| 28406 | 1599786908 | K782018 | LEADS, IMPLANTABLE CARDIAC PACEMAKERS | DTB | 1979-06-04 |
| 211522 | 1599786908 | K782018 | LEADS, IMPLANTABLE CARDIAC PACEMAKERS | DTB | 1979-06-04 |
| 28406 | 1477346170 | K212340 | EMBOGUARD Balloon Guide Catheter | QJP | 2021-12-17 |
| 28406 | 1794539546 | K210627 | Breezeway II | DYB | 2021-06-03 |
| 28406 | 1216711455 | K151951 | Destino Reach | DYB | 2015-09-22 |
| 211522 | 1216711455 | K151951 | Destino Reach | DYB | 2015-09-22 |
| 28406 | 1653164369 | K143463 | IS4/DF4 Port Plug | DTD | 2015-03-19 |
| 211522 | 1653164369 | K143463 | IS4/DF4 Port Plug | DTD | 2015-03-19 |
| 211522 | 1484701357 | K141399 | FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM | GZB | 2014-10-10 |
| 23563 | 1240148562 | K140917 | INTRODUCER, MODEL ADELANTE MAGNUM | DYB | 2014-07-09 |
| 28406 | 1346780614 | K140917 | INTRODUCER, MODEL ADELANTE MAGNUM | DYB | 2014-07-09 |
| 211522 | 1346780614 | K140917 | INTRODUCER, MODEL ADELANTE MAGNUM | DYB | 2014-07-09 |
| 23563 | 1069013562 | K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH | DYB | 2014-04-17 |
| 28406 | 1270427180 | K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH | DYB | 2014-04-17 |
| 211522 | 1270427180 | K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH | DYB | 2014-04-17 |
| 23563 | 1384332130 | K130843 | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE | DRC | 2014-01-08 |
| 28406 | 1633298295 | K130843 | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE | DRC | 2014-01-08 |
| 211522 | 1633298295 | K130843 | SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE | DRC | 2014-01-08 |
| 28406 | 1032165571 | K130633 | INTRODUCER SETS, MODEL ADELANTE RADIAL | DYB | 2014-02-13 |
| 211522 | 1032165571 | K130633 | INTRODUCER SETS, MODEL ADELANTE RADIAL | DYB | 2014-02-13 |
| 23563 | 1392411599 | K130633 | INTRODUCER SETS, MODEL ADELANTE RADIAL | DYB | 2014-02-13 |
| 28406 | 1235658489 | K122960 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | DYB | 2012-12-13 |
| 211522 | 1235658489 | K122960 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | DYB | 2012-12-13 |
| 23563 | 1956006568 | K122960 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | DYB | 2012-12-13 |
| 23563 | 1690085602 | K122958 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | DYB | 2012-12-13 |
| 28406 | 1805969866 | K122958 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | DYB | 2012-12-13 |
| 211522 | 1805969866 | K122958 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | DYB | 2012-12-13 |
| 23563 | 1043973770 | K122084 | INTRODUCER SET, MODEL ADELANTE-S SERIES | DYB | 2012-08-29 |
| 28406 | 1507239581 | K122084 | INTRODUCER SET, MODEL ADELANTE-S SERIES | DYB | 2012-08-29 |
| 211522 | 1507239581 | K122084 | INTRODUCER SET, MODEL ADELANTE-S SERIES | DYB | 2012-08-29 |
| 23563 | 1246599471 | K120459 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | DYB | 2012-06-29 |
| 28406 | 1646516507 | K120459 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | DYB | 2012-06-29 |
| 211522 | 1646516507 | K120459 | STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO | DYB | 2012-06-29 |
| 23563 | 1667071760 | K101497 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | DYB | 2010-10-20 |
| 28406 | 1925168753 | K101497 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | DYB | 2010-10-20 |
| 211522 | 1925168753 | K101497 | DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY | DYB | 2010-10-20 |
| 28406 | 1170844982 | K092118 | ANGIOGRAPHIC CATHETER, MODEL ANGIOS | DQO | 2010-01-13 |
| 211522 | 1170844982 | K092118 | ANGIOGRAPHIC CATHETER, MODEL ANGIOS | DQO | 2010-01-13 |
| 23563 | 1695098864 | K092118 | ANGIOGRAPHIC CATHETER, MODEL ANGIOS | DQO | 2010-01-13 |
| 28406 | 1287826867 | K090114 | MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S | DYB | 2009-06-04 |
| 211522 | 1287826867 | K090114 | MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S | DYB | 2009-06-04 |
| 23563 | 1288579789 | K090114 | MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S | DYB | 2009-06-04 |
| 23563 | 1288611935 | K081986 | SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE | DRC | 2008-11-14 |
| 28406 | 2042030495 | K081986 | SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE | DRC | 2008-11-14 |
| 211522 | 2042030495 | K081986 | SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE | DRC | 2008-11-14 |
| 28406 | 1595798189 | K081052 | OCCLUSION BALLOON CATHETER, MODEL VENOS | DYG | 2008-06-18 |
| 211522 | 1595798189 | K081052 | OCCLUSION BALLOON CATHETER, MODEL VENOS | DYG | 2008-06-18 |
| 23563 | 1799653712 | K081052 | OCCLUSION BALLOON CATHETER, MODEL VENOS | DYG | 2008-06-18 |
| 28406 | 1235143569 | K073100 | INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S | DYB | 2007-11-30 |
| 211522 | 1235143569 | K073100 | INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S | DYB | 2007-11-30 |
| 23563 | 1468436181 | K073100 | INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S | DYB | 2007-11-30 |
| 23563 | 1202807214 | K072770 | TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) | LDF | 2008-01-22 |
| 28406 | 1800229967 | K072770 | TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) | LDF | 2008-01-22 |
| 211522 | 1800229967 | K072770 | TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) | LDF | 2008-01-22 |
| 28406 | 1218949951 | K070926 | ELECTRODE/EXTENSION CABLES, MODELS ATAR | IKD | 2007-06-07 |
| 211522 | 1218949951 | K070926 | ELECTRODE/EXTENSION CABLES, MODELS ATAR | IKD | 2007-06-07 |
| 23563 | 1937919877 | K070926 | ELECTRODE/EXTENSION CABLES, MODELS ATAR | IKD | 2007-06-07 |
| 23563 | 1178928989 | K041809 | PERMANENT PACING LEAD, MODEL PY2 | DTB | 2004-08-06 |
| 28406 | 2038952391 | K041809 | PERMANENT PACING LEAD, MODEL PY2 | DTB | 2004-08-06 |
| 211522 | 2038952391 | K041809 | PERMANENT PACING LEAD, MODEL PY2 | DTB | 2004-08-06 |
| 23563 | 1386312201 | K040569 | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU | DTB | 2004-04-07 |
| 28406 | 1460818959 | K040569 | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU | DTB | 2004-04-07 |
| 211522 | 1460818959 | K040569 | PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU | DTB | 2004-04-07 |
| 23563 | 1040163672 | K031164 | PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV | DTD | 2003-06-19 |
| 28406 | 2055457987 | K031164 | PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV | DTD | 2003-06-19 |
| 211522 | 2055457987 | K031164 | PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV | DTD | 2003-06-19 |
| 23563 | 1236133671 | K024156 | PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR | DTD | 2003-01-14 |
| 28406 | 1994781122 | K024156 | PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR | DTD | 2003-01-14 |
| 211522 | 1994781122 | K024156 | PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR | DTD | 2003-01-14 |
| 28406 | 1617252995 | K024053 | PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB | DTB | 2003-01-31 |
| 211522 | 1617252995 | K024053 | PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB | DTB | 2003-01-31 |
| 23563 | 2046151528 | K024053 | PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB | DTB | 2003-01-31 |
| 23563 | 1662766125 | K020669 | PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB | DTB | 2002-03-28 |
| 28406 | 1890664488 | K020669 | PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB | DTB | 2002-03-28 |
| 211522 | 1890664488 | K020669 | PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB | DTB | 2002-03-28 |
| 28406 | 1442282067 | K010787 | PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS | DTD | 2001-05-22 |
| 211522 | 1442282067 | K010787 | PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS | DTD | 2001-05-22 |
| 23563 | 1584069350 | K010787 | PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS | DTD | 2001-05-22 |
| 211522 | 1210557817 | ||||
| 23563 | 1040163672 | ||||
| 23563 | 1043415764 | ||||
| 23563 | 1043973770 | ||||
| 23563 | 1050135649 | ||||
| 23563 | 1069013562 | ||||
| 28406 | 1091705528 | ||||
| 28406 | 1151752115 | ||||
| 28406 | 1152773835 | ||||
| 23563 | 1154189925 | ||||
| 28406 | 1210557817 | ||||
| 23563 | 1236133671 | ||||
| 23563 | 1240148562 | ||||
| 23563 | 1246599471 | ||||
| 23563 | 1279079815 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DYB | 33 | 2021-06-03 |
| LDF | 18 | 2008-01-22 |
| DTB | 17 | 2004-08-06 |
| DTD | 14 | 2015-03-19 |
| DRC | 6 | 2014-01-08 |
| DQO | 3 | 2010-01-13 |
| DYG | 3 | 2008-06-18 |
| IKD | 3 | 2007-06-07 |
| PIM | 2 | 2015-01-14 |
| LWS | 2 | 2012-09-28 |
| QJP | 1 | 2021-12-17 |
| QBI | 1 | 2018-04-09 |
| PSR | 1 | 2017-10-06 |
| GZB | 1 | 2014-10-10 |
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
Oscor Inc.
OSCOR MEDICAL CORP.
OSCOR MEDICAL CORP.
OSCOR MEDICAL CORP.
OSCOR MEDICAL CORP.
OSCOR MEDICAL CORP.
OSCOR MEDICAL CORP.
OSCOR MEDICAL CORP.
OSCOR MEDICAL CORP.
OSCOR MEDICAL CORP.
OSCOR MEDICAL CORP.
OSCOR MEDICAL CORP.
OSCOR MEDICAL CORP.
OSCOR MEDICAL CORP.
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