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Cardiovascular

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

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RecordFirmDate
SYNERGYST II,ELITE & LEGEND PULSE GENERATORS (P890003/S047)Medtronic, Inc.1996-10-30
APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK (P880006/S024)St. Jude Medical, Inc.1996-10-30
MEDTRONIC 9766A/9766AL PROGRAMMING HEAD (P890003/S046)Medtronic, Inc.1996-10-30
ACS TX2000TM CORONARY DILATION CATHETER (P810046/S165)Advanced Cardiovascular Systems, Inc.1996-10-25
MEDTRONIC(R) FALCON(R) CORONARY BALLOON DILATATION CATHETERS (P870036/S040)Medtronics Interventional Vascular1996-10-25
MODEL 7220 B/C/D/E JEWEL(R) PLUS, 7202 D/E, 7219 BDE, 7221 B/C/CXDE (P900061/S027)Medtronic Cardiac Rhythm Disease Management1996-10-22
VIGOR(TM) DR PACEMAKER SYSTEM (P940031/S004)Boston Scientific1996-10-18
CARPENTIER-EDWARDS(R) BIOPROSTHESIS, MODELS 2625 AND 6625 (P870056/S003)Edwards Lifesciences, LLC1996-10-17
CARPENTIER-EDWARDS(R) DURAFLEX(TM) BIOPROSTHESIS, MODELS 6625-LP AND 6625 ESR-LP (P870077/S003)Edwards Lifesciences, LLC1996-10-17
CARPENTIER-EDWARDS(R) PERIMOUNT(TM) BIOPROSTHESIS, MODEL 2700, AND CARPENTIER-EDWARDS(R) PERIMOUNT(TM) RSR BIOPROSTHESIS (P860057/S004)Edwards Lifesciences, LLC1996-10-17
MARATHON PACING SYSYTEM (P910020/S016)Boston Scientific1996-10-16
DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS (P950037)Biotronik, Inc.1996-10-11
PHOENIX 2 AND PARAGON II PACING SYSTEMS (P830045/S051)St. Jude Medical, Inc.1996-10-09
SYNCHRONY,SYNCHRONY II & III SOLUS, SOLUS II & TRIOLOGY PACEMAKERS (P880086/S035)ABBOTT MEDICAL1996-10-09
WALLSTENT(R) TIPS ENDOPROSTHESIS (P930031/S002)Boston Scientific Corp1996-10-07
REFLEX MODELS 8218 AND 822OE; REFLEX DDD MODELS 8223E AND 8224; AND SIMPLEX MODEL 8232 PULSE GENERATORS (P820018/S070)St. Jude Medical, Inc.1996-10-03
Angio Seal Vascular Closure Device (P930038)Terumo Medical Corporation1996-09-30
SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (PTCA) CATHETER (P860019/S115)Scimed Life Systems, Inc.1996-09-30
TRILOGY DR+ PULSE GENERATOR MODELS 2360L AND 2364L PULSE GENERATORS MODELS 2360L AND 2364L (P880086/S036)ABBOTT MEDICAL1996-09-30
ATAKR(TM) RFCA SYSTEM (P930029/S004)Medtronic, Inc.1996-09-30
META(TM) III PULSE GENERATOR MODELS 1206, 1206E, 1206M (P880038/S033)St. Jude Medical, Inc.1996-09-30
ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM'S DYNAGLIDE(TM) FOOT PEDAL (P900056/S017)Boston Scientific Corp1996-09-27
MEDTRONIC(R) MILLENIA (TM) FAMILY OF CORONARY BALLOON DILATATION CATHETERS (P870036/S038)Medtronics Interventional Vascular1996-09-25
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S017)ABBOTT MEDICAL1996-09-25
MEDTRONIC JEWEL CARDIOVERTER DEFIBRILLATOR (P900061/S023)Medtronic Cardiac Rhythm Disease Management1996-09-25
BIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD (P830060/S041)Boston Scientific1996-09-20
MEDTRONIC 9891 BASELINE SOFTWARE/9891 A EPS (P890003/S044)Medtronic, Inc.1996-09-18
FACT(TM) BALLOON CORONARY DILATION CATHETER (P910031/S008)Abbott Vascular Devices1996-09-17
IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) (P910019/S002)Intensive Technology, Inc.1996-09-17
LEOCOR CORFLO(TM) MODEL 7.5PT & PICO-ST COATED CAT (P890001/S016)Leocor, Inc.1996-09-17
COOK BIRD'S NEST VENA CAVA FILTER (P850049/S005)Cook, Inc.1996-09-17
ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM'S DYNAGLIDE(TM) FOOT PEDAL (P900056/S016)Boston Scientific Corp1996-09-13
ACS(R) PINKERTON .018(TM) CORONARY DILATION CATHETER (P810046/S163)Advanced Cardiovascular Systems, Inc.1996-09-13
CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S020)ABBOTT MEDICAL1996-09-09
MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 (P950024)Medtronic, Inc.1996-09-06
ATAKR RADIOFREQUENCY CATHETER ABLATION (RFCA) SYSTEM (P930029/S007)Medtronic, Inc.1996-09-06
ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM) (P900056/S019)Boston Scientific Corp1996-09-04
MECHANICAL HEART VALVE SJM(R) MASTER SERIES (P810002/S041)ABBOTT MEDICAL1996-09-04
CHUBBY(TM) PTCA CATHETERS (P880027/S040)Boston Scientific1996-09-04
USCI(R) PROCROSS(TM) OVER-THE-WIRE BALLOON DILATION WITH RELY(TM) BALLOON MATERIAL AND HYDRO/PEL(R) COATING (P790017/S059)Medtronic, Ireland1996-09-03
MEDTRONIC FALCON CORONARY BALLOON DILATATION CATHETERS (P870036/S039)Medtronics Interventional Vascular1996-08-30
SCIMED RANGER PTCA CATHETERS (P860019/S112)Scimed Life Systems, Inc.1996-08-29
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S013)Corcym S.r.l.1996-08-27
SCIMED NC BANDIT PTCA CATHETER (P860019/S114)Scimed Life Systems, Inc.1996-08-27
RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS (P940008/S003)Boston Scientific1996-08-22
FACT(TM)AND ARC BALLOON CORNARY DILATATION CATHETERS (P910031/S009)Abbott Vascular Devices1996-08-20
RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS (P940008/S002)Boston Scientific1996-08-20
INTERTACH II MODELS 262-16 (P860007/S018)Boston Scientific1996-08-19
MEDTRONIC-HALL PROSTHETIC HEART VALVE (P790018/S027)Medtronic Cardiac Surgery1996-08-19
RELAY/DASH/STRIDE/DART PACING SYSTEMS (P910020/S015)Boston Scientific1996-08-19
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S019)Abiomed Cardiovascular, Inc.1996-08-19
COSMOS/NOVA/QUANTUM/SUPRIMA/PULSE GENERATORS (P830026/S067)Boston Scientific1996-08-19
MEDTRONIC(R) POLYURETHANE STEROID-ELUTING LEAD (P830061/S026)Medtronic Cardiac Rhythm Disease Management1996-08-12
MEDTRONIC SILICONE STEROID-ELUTING LEAD (P850089/S034)Medtronic Cardiac Rhythm Disease Management1996-08-12
MEDTRONIC VDD STEROID-ELUTING LEAD (P890003/S045)Medtronic, Inc.1996-08-12
MEDTRONIC(R) SCREW-IN STEROID ELUTING LEAD (P930039/S001)Medtronic, Inc.1996-08-12
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S011)Corcym S.r.l.1996-08-12
MEDTRONIC SPRINT TM MODEL 6932 LEAD (P920015/S010)Medtronic, Inc.1996-08-06
MEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK (P900061/S028)Medtronic Cardiac Rhythm Disease Management1996-08-06
VASOSEAL (TM) (P920004/S001)St. Jude Medical, Inc.1996-08-01
VASOSEAL (TM) (P920004/S002)St. Jude Medical, Inc.1996-08-01
UNITY MODEL 292-06 SINGLE PASS PULSE GENERATOR (P910020/S012)Boston Scientific1996-07-31
SIMPSON-ROBERT PTCA CATHETER ACS RX LIFESTREAM AND ACS OTW LIFESTREAM PTCA CATHETERS WITH 30MM BALLOON LENGTH (P810046/S161)Advanced Cardiovascular Systems, Inc.1996-07-29
MEDTRONIC SPRINT TM MODEL 6932 LEAD (P920015/S011)Medtronic, Inc.1996-07-26
THOR PTCA DILATION CATHETERS (P880003/S060)Cordis Corp.1996-07-26
META DDDR PACING SYSTEM (P900070/S009)St. Jude Medical, Cardiac Rhythm Management Divisi1996-07-23
REFLEX MODEL 8223E (P820018/S065)St. Jude Medical, Inc.1996-07-23
MEDA-MV PACING SYSTEM (P880038/S028)St. Jude Medical, Inc.1996-07-23
AUTIMA/AURORA CARDIAC PACING SYSTEM (P820018/S063)St. Jude Medical, Inc.1996-07-23
MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032/S003)Pace Medical1996-07-19
MEDTRONIC MODEL 5348 TEMPORARY PACEMAKER KEYPAD COMPONENT (P820003/S073)Medtronic Cardiac Rhythm Disease Management1996-07-16
MEDA-MV PACING SYSTEM (P880038/S029)St. Jude Medical, Inc.1996-07-11
META DDDR PACING SYSTEM (P900070/S010)St. Jude Medical, Cardiac Rhythm Management Divisi1996-07-11
REFLEX MODEL 8223E (P820018/S066)St. Jude Medical, Inc.1996-07-11
THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S001)Thoratec Laboratories Corp.1996-07-10
MAESTRO(R) II MODEL 533 PACEMAKER SYSTEM (P860027/S011)Cardiac Control Systems, Inc.1996-07-09
MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333 (P890039/S015)Cardiac Control Systems, Inc.1996-07-09
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S010)Corcym S.r.l.1996-07-02
GOLDIE(TM) AND GOLDIE(TM) LONGY PTCA CATHETERS (P880027/S039)Boston Scientific1996-07-01
SCIMED(R) SURPASS(TM) PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (P860019/S111)Scimed Life Systems, Inc.1996-07-01
MEDTRONIC MODEL 7221 B/C/CX/D/E MICRO JEWEL W/MODEL 5434 ACTIVE CAN EMULATOR AND MODEL 9894 (P900061/S022)Medtronic Cardiac Rhythm Disease Management1996-07-01
MEDTRONIC THERA, PRODIGY AND PREVA PULSE GENERATORS (P890003/S043)Medtronic, Inc.1996-07-01
NETWORK PROGRAMMER MODEL 9602 (P900070/S012)St. Jude Medical, Cardiac Rhythm Management Divisi1996-06-25
NETWORK PROGRAMMER MODEL 9602 (P880038/S031)St. Jude Medical, Inc.1996-06-25
NETWORK PROGRAMMER MODEL 9602 (P820018/S069)St. Jude Medical, Inc.1996-06-25
META DDDR PACING SYSTEM (P900070/S011)St. Jude Medical, Cardiac Rhythm Management Divisi1996-06-21
VISTA DDD MODEL 942 & 944 AND SOFTWARE MODULE MODEL 2052 (P840068/S019)Boston Scientific1996-06-19
LEOCOR PERCUTANEOUS ANGIOPLASTY CATHETER (PTCA), MODEL 5S, LEOCOR CORFLO MODEL 7.5PT COATED PTCA, AND CORFLO HEMO PUMP (P890001/S011)Leocor, Inc.1996-06-13
LEOCOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER AND LEOCOR PTCA CATHETER MODEL PICO-ST (COATED) (P890001/S014)Leocor, Inc.1996-06-13
CORDIS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY DILATATION CATHETERS (P880003/S054)Cordis Corp.1996-06-13
ASUKA AND ASUKA LONGY OVER-THE-WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS (P880027/S038)Boston Scientific1996-06-12
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S014)ABBOTT MEDICAL1996-06-11
CADET TIERED THERAPY DEFIBRILLATOR SYSTEM (P910023/S018)ABBOTT MEDICAL1996-06-11
ATAKR RFCA SYSTEM (P930029/S005)Medtronic, Inc.1996-06-11
SCIMED WAVE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) (P860019/S108)Scimed Life Systems, Inc.1996-06-10
LEOCOR PICO RUNNER(TM) PTCA CATHETER (P890001/S015)Leocor, Inc.1996-06-07
CORDIS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS (P880003/S059)Cordis Corp.1996-06-05
CATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER (P910031/S007)Abbott Vascular Devices1996-05-30
RX5000 PROGRAMMER MODEL 522-12 (P830026/S065)Boston Scientific1996-05-30
WALLSTENT(R) ILIAC ENDOPROSTHESIS (P940019)Boston Scientific Scimed, Inc.1996-05-28
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