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Cardiovascular

28,927 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
MEDTRONIC MODEL 7219C/7202C JEWEL ACTIVE CAN MANAGEMENT SYSTEMS (P900061/S014)Medtronic Cardiac Rhythm Disease Management1995-12-06
CORDIA PTCA DILATION CATHETERS (P880003/S051)Cordis Corp.1995-12-06
ACS SIMPSON-ROBERT CORONARY DILATATION CATHETER (P810046/S157)Advanced Cardiovascular Systems, Inc.1995-12-05
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S050)Cordis Corp.1995-12-05
INOUE BALLOON CATHETER (P910054/S001)Toray Industries (America), Inc.1995-11-30
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S017)Abiomed Cardiovascular, Inc.1995-11-30
MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM (P900061/S018)Medtronic Cardiac Rhythm Disease Management1995-11-29
THE ST. JUDE MEDICAL(R) MECHANICAL HEART VALVE SJM(R) MASTERS SERIES (P810002/S036)ABBOTT MEDICAL1995-11-28
RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS (P940008)Boston Scientific1995-11-28
ENDOTAK(R) LEAD SYSTEM (P910073/S015)Boston Scientific1995-11-27
AMERICAN EDWARDS LABORATORIES HYBRID PTCA CATHETER, PURSUIT 14 PTCA CATHETER (P850021/S029)Abbott Vascular, Inc.1995-11-27
DARDIK BIOGRAFT(R) MOD. HUMAN UMBILICAL VEIN GRAFT (P780002/S012)Synovis Surgical Innovations1995-11-24
SCHNEIDER MICROSOFTRAC PTCA CATHETER SCHNEIDER FREEFLIGHT 20/30/40 PTCA CATHETER (P880027/S036)Boston Scientific1995-11-21
VENTAK P2 AICD SYSTEM (P930035/S003)Boston Scientific1995-11-20
DELTA PACEMAKER SYSTEM (P840068/S025)Boston Scientific1995-11-20
VENTAK(R) PRX (TM) II AICD SYSTEM (P910077/S007)Boston Scientific1995-11-20
VENTAK(R) P MODEL 1600 (P890061/S010)Boston Scientific1995-11-20
VENTAK(R) AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIB (P830060/S038)Boston Scientific1995-11-20
SCIMED PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETERS AND TRAPPER EXCHANGE DEVICE (P860019/S102)Scimed Life Systems, Inc.1995-11-20
TCI HEARTMATE(R) 1000A IP LVAD (P920014/S002)Thoratec Corp1995-11-17
AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM (P830045/S050)St. Jude Medical, Inc.1995-11-13
AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM (P880086/S034)ABBOTT MEDICAL1995-11-13
AFP CARDIAC PACING SYSTEM, SENSOLOG CARDIAC PACING SYSTEM, AND SYNCHRONY CARDIAC PACING SYSTEM (P880006/S023)St. Jude Medical, Inc.1995-11-13
EPT-1000 TC CARDIAC ABLATION SYSTEM WITH TEMPERATURE CONTROL (P920047/S001)Boston Scientific Corp1995-11-08
ACS SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETER (P810046/S156)Advanced Cardiovascular Systems, Inc.1995-11-07
MODEL 9881E SOFTWARE (9881E 217214 REVISION:C) (P900061/S019)Medtronic Cardiac Rhythm Disease Management1995-11-06
TRILOGY PULSE GENERATOR MODELS 235OL, 2250L, AND 2308L (P880086/S033)ABBOTT MEDICAL1995-11-01
SYNCHRONY III AND PARAGON III DUAL-CHAMBER PULSE GENERATORS (P880086/S032)ABBOTT MEDICAL1995-11-01
MEDTRONIC SINGLE CHAMBER PACEMAKERS (P850051/S051)Medtronic, Inc.1995-10-31
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S008)ABBOTT MEDICAL1995-10-31
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S022)Cordis Corp.1995-10-31
MEDTRONIC MODEL 5348 TEMPORARY PACEMAKERS (P820003/S070)Medtronic Cardiac Rhythm Disease Management1995-10-31
SYNERGYST II MEDTRONIC MODEL 9889E SOFTWARE (P890003/S042)Medtronic, Inc.1995-10-31
SCIMED LEAP EXPRESS PLUS (P860019/S107)Scimed Life Systems, Inc.1995-10-31
MEDTRONIC(R) CAPSURE(R) SP TRANSVENOUS PACING LEAD (P830061/S025)Medtronic Cardiac Rhythm Disease Management1995-10-31
MEDTRONIC(R) THERA(TM) PULSE GENERATORS (P890003/S037)Medtronic, Inc.1995-10-31
SCIMED NC EXPRESS PLUS HD PTCA CATHETER (P860019/S105)Scimed Life Systems, Inc.1995-10-31
CAPSURE(R) AND CAPSURE(R)SP LEADS (P850089/S032)Medtronic Cardiac Rhythm Disease Management1995-10-31
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S011)ABBOTT MEDICAL1995-10-31
SCIMED NC EXPRESS PLUS PTCA CATHETER (P860019/S106)Scimed Life Systems, Inc.1995-10-31
CARBOMEDICS(R) PROSTHETIC HEART VALVE (CPHV) (P900060/S007)Corcym S.r.l.1995-10-26
MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER (P880065/S002)Boston Scientific Corp1995-10-23
SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER (P840040/S049)Boston Scientific Corp1995-10-19
SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER (P840040/S050)Boston Scientific Corp1995-10-19
REFLEX MODEL 8223E (P820018/S068)St. Jude Medical, Inc.1995-10-10
MODEL 6888 LEAD TUNNELER ACCESSORY (P830060/S040)Boston Scientific1995-10-03
ORACLE(TM) CORONARY BALLOON DILATATION CATHETER (P910031/S002)Abbott Vascular Devices1995-10-03
NC BANDIT PTCA CATHETER (P860019/S104)Scimed Life Systems, Inc.1995-10-02
WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031)Boston Scientific Corp1995-09-29
VASOSEAL (TM) (P920004)St. Jude Medical, Inc.1995-09-29
MAESTRO(R) II MODEL 533 PACEMAKER SYSTEM (P860027/S010)Cardiac Control Systems, Inc.1995-09-26
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S049)Cordis Corp.1995-09-18
VENTAK(R) P3 AICD(TM) SYSTEM (P930035/S001)Boston Scientific1995-09-08
BIOTRONIK SOFTWARE MODULE SWM 600 V.D05U01 (P820076/S017)Biotronik, Inc.1995-09-07
SEQUEL CONVERTIBLE RAPID EXCHANGE PTCA CATHETER (P840040/S048)Boston Scientific Corp1995-08-29
MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S001)Pace Medical1995-08-28
MODEL 0010 BIPOLAR ENDOCARDIAL LEAD (P830060/S039)Boston Scientific1995-08-28
LEAP EXPRESS PLUSS (P860019/S101)Scimed Life Systems, Inc.1995-08-22
JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM (P900061/S008)Medtronic Cardiac Rhythm Disease Management1995-08-22
JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM (P900061/S012)Medtronic Cardiac Rhythm Disease Management1995-08-22
JEWEL ACTIVE CAN & JEWEL PLUS ACTIVE CAN ARRHYTHMIA MGMT SYSTEMS (P900061/S015)Medtronic Cardiac Rhythm Disease Management1995-08-17
LEAP EXPRESS PLUSS (P860019/S100)Scimed Life Systems, Inc.1995-08-17
SIMPSON CORONARY ATHEROCATH(TM) (P890043/S027)Abbott Vascular1995-08-17
MEDTRONIC(R) MDL 6966, 6936, 6963 TRANSVENE(R) AND MODEL 6939 AND 6999 SUBCUTANEOUS PATCH LEADS. (P920015/S006)Medtronic, Inc.1995-08-17
LEAP EXPRESS PLUSS (P860019/S103)Scimed Life Systems, Inc.1995-08-15
MEDTRONIC(R) THERA(TM) PULSE GENERATORS (P890003/S040)Medtronic, Inc.1995-08-15
MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S004)Medtronic, Inc.1995-08-14
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S006)Corcym S.r.l.1995-08-14
ROTABLATOR(R) (P900056/S009)Boston Scientific Corp1995-08-14
ENDOTAK(R) LEAD SYSTEM (P910073/S017)Boston Scientific1995-08-14
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S009)Corcym S.r.l.1995-08-14
E P TECH EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S004)Boston Scientific Corp1995-08-14
MEDA-MV PACING SYSTEM (P880038/S030)St. Jude Medical, Inc.1995-08-14
CORDIS TRASKAR 18 PTCA DILITATION CATHETERS (P880003/S048)Cordis Corp.1995-08-14
E P TECH CARDIAC ABLATION SYSTEM (P920047/S002)Boston Scientific Corp1995-08-14
MECHANICAL HEART VALVE SJM(R) MASTER SERIES (P810002/S037)ABBOTT MEDICAL1995-08-11
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S018)Cordis Corp.1995-08-04
CORDIS PTCA DILITATION CARTHETERS (P880003/S025)Cordis Corp.1995-08-04
VENTAK(R) PRX(R) AICD(TM) SYSTEM (P910077/S004)Boston Scientific1995-08-03
MODEL 5420 PATIENT CABLE (P900061/S016)Medtronic Cardiac Rhythm Disease Management1995-08-01
JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM (P900061/S011)Medtronic Cardiac Rhythm Disease Management1995-08-01
ENDOTAK(R) LEAD SYSTEM (P910073/S007)Boston Scientific1995-08-01
ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S035)ABBOTT MEDICAL1995-07-31
MEDTRONIC(R) THERA(TM) PULSE GENERATORS (P890003/S036)Medtronic, Inc.1995-07-31
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S005)Spectranetics Corp.1995-07-31
SCHNEIDER FREEHAND(R) PTCA CATHETERS (P880027/S037)Boston Scientific1995-07-31
ROTABLATOR(R) (P900056/S006)Boston Scientific Corp1995-07-12
KELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS. (P870054/S014)Cook Pacemaker Corp.1995-07-12
AUTIMA/AURORA CARDIAC PACING SYSTEM (P820018/S061)St. Jude Medical, Inc.1995-07-12
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001/S008)Spectranetics Corp.1995-07-12
HYBRID (PTCA) CATHETER (P850021/S030)Abbott Vascular, Inc.1995-07-12
SIMPSON CORONARY ATHEROCATH(TM),SCA-EX(TM), SCA-EX 7 FRENCH GRAFT AND ATHEROCATH-GTO(R) (P890043/S028)Abbott Vascular1995-07-12
META DDDR PACING SYSTEM (P900070/S007)St. Jude Medical, Cardiac Rhythm Management Divisi1995-07-12
VASCUTEK GELSOFT(TM) VASCULAR GRAFT (P890045/S001)Carbomedics, Inc.1995-07-05
ATAKR(TM) RFCA SYSTEM AND THR RF MARINR NTC (P930029/S002)Medtronic, Inc.1995-06-23
JEWEL(TM) PCD ARRHYTHMIA CONTROL SYSTEM (P900061/S009)Medtronic Cardiac Rhythm Disease Management1995-06-23
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S015)Abiomed Cardiovascular, Inc.1995-06-22
SYNCHRONY(R) CARDIAC PACING SYSTEM (P880086/S031)ABBOTT MEDICAL1995-06-21
VIGOR(TM) DR PACEMAKER SYSTEM (P940031)Boston Scientific1995-06-21
USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S004)Usci, Div. C.R. Bard, Inc.1995-06-14
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