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Cardiovascular

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

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RecordFirmDate
HYBRID (PTCA) CATHETER (P850021/S025)Abbott Vascular, Inc.1994-07-26
VASCUTEK GELSEAL(TM) VASCULAR GRAFT (P890045/S006)Carbomedics, Inc.1994-07-22
MODEL 7217D PCD(TM) TACHYARRHYTHMIA CONTROL SYS. (P900061/S006)Medtronic Cardiac Rhythm Disease Management1994-07-20
MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S003)Medtronic, Inc.1994-07-20
AFP CARDIAC PACING SYS. MODEL 385 G FUNCTION PACK (P830045/S043)St. Jude Medical, Inc.1994-07-12
SYNCHRONY PACING SYS. MODEL 3039 FUNCTION PACK (P880086/S024)ABBOTT MEDICAL1994-07-12
AFP CARDIAC PACING SYS. MODEL 3039 FUNCTION PACK (P830045/S044)St. Jude Medical, Inc.1994-07-12
SENSOLOG (R)MODEL 3039 FUNCTION PACK (P880006/S018)St. Jude Medical, Inc.1994-07-12
SYNCHRONY PACING SYS. MODEL 385 FUNCTION PACK (P880086/S023)ABBOTT MEDICAL1994-07-12
ACS RX FLOWTRACK(TM) LONG COR. DILITATION CATH. (P810046/S148)Advanced Cardiovascular Systems, Inc.1994-07-11
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S005)Corcym S.r.l.1994-07-08
INOUE BALLOON CATHETER (P910054)Toray Industries (America), Inc.1994-06-28
POBA(TM) AND SAAVY(TM) PTCA CATHETERS (P840040/S040)Boston Scientific Corp1994-06-24
MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S001)Medtronic, Inc.1994-06-24
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S007)Abiomed Cardiovascular, Inc.1994-06-21
VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR (P910077)Boston Scientific1994-06-17
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S004)ABBOTT MEDICAL1994-06-16
ACS CORONARY DILITATION CATHETERS (P810046/S150)Advanced Cardiovascular Systems, Inc.1994-06-14
EXCIMER LASER (P900032/S019)Spectranetics Corp.1994-06-14
ACS RX PRIMAFLOW (TM) CORO.DILATION CATHETER (P810046/S131)Advanced Cardiovascular Systems, Inc.1994-06-14
EXCIMER LASER (P900032/S018)Spectranetics Corp.1994-06-14
ACS EDGE (TM)DILATATION CATHETERS (P810046/S144)Advanced Cardiovascular Systems, Inc.1994-06-13
RELAY-DASH PACING SYSTEM (P910020/S005)Boston Scientific1994-06-09
MULTIPROGRAMMABLE TACHYARRHYTHMIA CONTROL SYSTEM (P900061/S001)Medtronic Cardiac Rhythm Disease Management1994-06-01
CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S011)Pacesetter Systems1994-05-25
MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015/S002)Medtronic, Inc.1994-05-25
MODEL 7217B PCD(TM) TACHYARRHYTHMIA CONTROL SYS. (P900061/S004)Medtronic Cardiac Rhythm Disease Management1994-05-25
MODEL 7217B PCD(TM) TACHYARRHYTHMIA CONTROL SYS. (P900061/S005)Medtronic Cardiac Rhythm Disease Management1994-05-25
SIMPSON CORONARY ATHEROCATH(R) (SCA(TM))DEV.MOD. (P890043/S020)Abbott Vascular1994-05-23
INTERTACH(R)II MODELS 262-16 (P860007/S013)Boston Scientific1994-05-17
COSMOS II MODELS 284-05,283-03 PULSE GENERATOR (P830026/S060)Boston Scientific1994-05-17
INTERTACH(R)II MODELS 262-16 (P860007/S014)Boston Scientific1994-05-17
COSMOS II MODELS 284-05,283-03 PULSE GENERATOR (P830026/S059)Boston Scientific1994-05-17
SCHNEIDER MYSTIC(TM) 20,30,40 MC PTCA CATHETERS (P880027/S030)Boston Scientific1994-05-17
SJM MODEL CAVG-304 PROTHESIS (P810002/S028)ABBOTT MEDICAL1994-05-10
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S002)ABBOTT MEDICAL1994-05-09
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S022)Medtronic Cardiac Surgery1994-05-09
SCIMED(R) LONG CRUISE (TM) PTCA CATHETER (P860019/S081)Scimed Life Systems, Inc.1994-05-06
COSMOS(R)II,NOVA(R)II,QUANTUM(R)II, & RX2000(R) (P830026/S056)Boston Scientific1994-05-06
RELAY/DASH/STRIDE & DART PACING SYSTEM (P910020/S003)Boston Scientific1994-05-06
MEDTRONIC ELITE II(TM) PULSE GENERATOR (P890003/S024)Medtronic, Inc.1994-04-29
SCIMED(R) PTCA CATHETER (P860019/S080)Scimed Life Systems, Inc.1994-04-29
SCHNEIDER MC RAIL(TM) 20,30,40 SLIDING RAIL PTCA (P880027/S028)Boston Scientific1994-04-29
SCIMED(R) (PTCA) CATHETER (P860019/S077)Scimed Life Systems, Inc.1994-04-29
MAESTRO(R) II SAVVI(TM) PACING SYS MODEL 325 & 333 (P890039/S013)Cardiac Control Systems, Inc.1994-04-29
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S017)Cordis Corp.1994-04-28
CORDIS SLEEK PLUS PTCA DILITATION CATHETERS (P880003/S024)Cordis Corp.1994-04-20
SCIMED(R) NC CRUISE(TM) PTCA CATHETER (P860019/S079)Scimed Life Systems, Inc.1994-04-14
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S004)Corcym S.r.l.1994-04-13
SCA-EX 7F GRAFT DEVICE (P890043/S022)Abbott Vascular1994-04-13
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S001)Corcym S.r.l.1994-04-13
SJM PYROLYTIC CARBON (P810002/S030)ABBOTT MEDICAL1994-04-13
4EDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S023)Medtronic Cardiac Surgery1994-04-12
SJM PYROLYTIC CARBON (P810002/S029)ABBOTT MEDICAL1994-04-08
MODEL 7217B PCD(TM) TACHYARRHYTHMIA CONTROL SYS. (P900061/S003)Medtronic Cardiac Rhythm Disease Management1994-04-04
ACS RX PERFUSION(TM) CORONARY DILITATION CATHETER (P810046/S147)Advanced Cardiovascular Systems, Inc.1994-04-04
SJM PYROLYTIC (R) CARBON HEART VALVE HEMODYNAMIC + (P810002/S025)ABBOTT MEDICAL1994-03-31
MODEL 7217B PCD(TM) TACHYARRHYTHMIA CONTROL SYS. (P900061/S002)Medtronic Cardiac Rhythm Disease Management1994-03-31
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023/S005)ABBOTT MEDICAL1994-03-28
SCIMED(R) LONG CRUISE (TM) PTCA CATHETER (P860019/S082)Scimed Life Systems, Inc.1994-03-18
ROTABLATOR(R) (P900056/S001)Boston Scientific Corp1994-03-17
CAPSURE(R) AND CAPSURE(R) SP PACING LEADS (P830061/S021)Medtronic Cardiac Rhythm Disease Management1994-03-17
MEDTRONIC(R) MODEL 4003M,4503M,4504M,& 4523 PACING (P830061/S022)Medtronic Cardiac Rhythm Disease Management1994-03-17
CAPSURE(R) AND CAPSURE(R)SP LEADS (P850089/S026)Medtronic Cardiac Rhythm Disease Management1994-03-17
SYNERGY(TM)II CONVERTIBLE RAPID EXCHANGE PTCA CATH (P840040/S036)Boston Scientific Corp1994-03-17
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S026)Trimedyne, Inc.1994-03-17
SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S016)Trimedyne, Inc.1994-03-17
MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER (P920032)Pace Medical1994-03-10
CAPSURE(R) AND CAPSURE(R)SP LEADS (P850089/S028)Medtronic Cardiac Rhythm Disease Management1994-03-04
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S027)Trimedyne, Inc.1994-03-01
MEDA-MV PACING SYSTEM (P880038/S025)St. Jude Medical, Inc.1994-02-24
META DDDR PACING SYSTEM (P900070/S005)St. Jude Medical, Cardiac Rhythm Management Divisi1994-02-24
AUTIMA (TM) MODEL 2251,& 2600 (P820018/S060)St. Jude Medical, Inc.1994-02-24
LEOCOR,INC. CORFLO(TM) MODEL 7.5S PTCA CATHETERS (P890001/S002)Leocor, Inc.1994-02-15
SJM MODEL CAVG-404 PROTHESIS (P810002/S027)ABBOTT MEDICAL1994-02-10
HYBRID (TM)&QUICK(TM) 14 PTCA CATHETER (P850021/S023)Abbott Vascular, Inc.1994-02-10
OEACH(TM).14,& READY(TM).14,PTCA CATHETER (P850021/S021)Abbott Vascular, Inc.1994-02-04
SCIMED(R) RALLY TURBO (TM) PTCA CATHETER (P860019/S075)Scimed Life Systems, Inc.1994-01-27
GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) (P910030/S002)Cook, Inc.1994-01-27
CORDIS PTCA DILATATION CATHETERS (P880003/S021)Cordis Corp.1994-01-27
SCIMED(R) RALLY TURBO (TM) PTCA CATHETER (P860019/S076)Scimed Life Systems, Inc.1994-01-27
ACS CORONARY DILATATION CATHETERS (P810046/S143)Advanced Cardiovascular Systems, Inc.1994-01-27
MEDTRONIC SYNERGYST II PULSE GENERATOR (P890003/S022)Medtronic, Inc.1994-01-26
MEDTRONIC VERSATRAX PULSE GENERATOR (P820003/S066)Medtronic Cardiac Rhythm Disease Management1994-01-26
MEDTRONIC ACTIVITRAX PULSE GENERATOR (P850051/S040)Medtronic, Inc.1994-01-26
ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S008)Abiomed Cardiovascular, Inc.1994-01-24
SIMPSON CORONARY ATHEROCATH(R) (GTO)(TM) DEVICE (P890043/S021)Abbott Vascular1994-01-12
CORDIS OLYMPIX,SLEUTH,& PREDATOR PTCA CATHETERS (P880003/S017)Cordis Corp.1994-01-12
STAT-PACE II (P840002/S001)Cardiocommand, Inc.1994-01-11
ROTABLATOR(R) (P900056/S002)Boston Scientific Corp1994-01-10
USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL (P790017/S044)Medtronic, Ireland1994-01-07
CORDIS PTCA DILATATION CATHETERS (P880003/S020)Cordis Corp.1994-01-07
USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL (P790017/S045)Medtronic, Ireland1994-01-07
ROTABLATOR(R) (P900056/S003)Boston Scientific Corp1994-01-07
SCIMED(R) PTCA CATHETER (P860019/S072)Scimed Life Systems, Inc.1994-01-04
CAPSURE(R) AND CAPSURE(R) SP PACING LEADS (P830061/S019)Medtronic Cardiac Rhythm Disease Management1993-12-21
CARBOMEDICS PROSTHETIC HEART VALVE (CPHV) (P900060/S002)Corcym S.r.l.1993-12-21
VENTAK MODEL 6910 LEAD ADAPTOR (P830060/S033)Boston Scientific1993-12-14
VENTAK P MODEL 6910 (P890061/S006)Boston Scientific1993-12-14
MEDTRONIC(R) TRANSVENE LEAD SYSTEM (P920015)Medtronic, Inc.1993-12-09
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