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Cardiovascular

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

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RecordFirmDate
HEMASHIELD(R) WOVEN DOUBLE VELOUR GRAFT (P840029/S015)Maquet Cardiovascular, LLC1993-05-11
HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM (P840029/S008)Maquet Cardiovascular, LLC1993-05-11
ACS RX PERFUSION(TM) DILATATION CATHETER (P810046/S138)Advanced Cardiovascular Systems, Inc.1993-05-04
LEOCOR PICOCATH(TM) MODEL PICO-ST (P890001/S005)Leocor, Inc.1993-05-04
MEDTRONIC(R)14K (TM)CORONARY DILATION CATHETER (P870036/S020)Medtronics Interventional Vascular1993-05-04
SCIMED(R) RALLY(TM) PTCA CATHETER (P860019/S060)Scimed Life Systems, Inc.1993-05-04
LEOCOR CORFLO(TM) MODEL 7.1PT (COATED) (P890001/S007)Leocor, Inc.1993-05-04
SIMPSON CORONARY ATHEROCATH(R) (SCA(TM)) (P890043/S017)Abbott Vascular1993-05-04
SCIMED(R) TRAPPER (TM) PTCA CATHETER (P860019/S061)Scimed Life Systems, Inc.1993-05-04
CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM (P910023)ABBOTT MEDICAL1993-04-30
SCIMED(R) ACE,LONG,GRAFT PTCA CATHETER (P860019/S063)Scimed Life Systems, Inc.1993-04-28
SLIDER(TM)/SUPER THIN CORONARY BALLOON DILATION C (P840040/S032)Boston Scientific Corp1993-04-28
ACS TEN (TM) CORONARY DILATATION CATHETER (P810046/S137)Advanced Cardiovascular Systems, Inc.1993-04-28
SCIMED(R) ACE,LONG,EXPR. HYPO-SEAL(TM) ACCESSORY (P860019/S064)Scimed Life Systems, Inc.1993-04-28
SCIMED(R) PTCA CATHETER (P860019/S059)Scimed Life Systems, Inc.1993-04-28
MEDTRONIC(R)14K (TM)CORONARY DILATION CATHETER (P870036/S019)Medtronics Interventional Vascular1993-04-28
META DDDR PACING SYSTEM (P900070/S004)St. Jude Medical, Cardiac Rhythm Management Divisi1993-04-21
AUTIMA (TM) MODEL 2251,& 2600 (P820018/S059)St. Jude Medical, Inc.1993-04-21
MEDTRONIC LEGEND II,MICRO MINIX MODIFICATIONS (P850051/S037)Medtronic, Inc.1993-04-21
MEDA-MV PACING SYSTEM (P880038/S024)St. Jude Medical, Inc.1993-04-19
CODEL 9600,4810,4510 5603,INTERFACE CABLE (P900070/S003)St. Jude Medical, Cardiac Rhythm Management Divisi1993-04-19
MODEL 5603,9600 PROGRAMMER INTERFACE CABLE (P820018/S057)St. Jude Medical, Inc.1993-04-19
MODEL 9600 AUX.INSTRUMENTS INTERFACE CABLE (P880038/S022)St. Jude Medical, Inc.1993-04-19
ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023/S002)Abiomed Cardiovascular, Inc.1993-04-08
MAESTRO(R) SAVVI(TM) SERIES 305 VDD PACING SYSTEM (P890039/S007)Cardiac Control Systems, Inc.1993-04-05
SCHNEIDER MYSTIC (TM) PTCA CATHETER (P880027/S024)Boston Scientific1993-03-23
ACS PRISM(TM) & PINKERTON .018(TM)COR.DIL. CATH. (P810046/S136)Advanced Cardiovascular Systems, Inc.1993-03-19
EXCIMER LASER MODEL DYMER (R) 200+ (P900032/S016)Spectranetics Corp.1993-03-18
ACS STACK 40-S(TM) CORONARY DILATATION CATH. (P810046/S134)Advanced Cardiovascular Systems, Inc.1993-03-18
RX222 MODEL 522-10 POCKET PROGRAMMER (P830026/S057)Boston Scientific1993-03-03
MEDTRONIC MODEL 9858 SOFTWARE DISKETTES (P890003/S019)Medtronic, Inc.1993-02-19
SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM (P910001)Spectranetics Corp.1993-02-19
MEDTRONIC BUSHBINDER(R) OMNIFLEX(TM) PTCA CATHETER (P870036/S013)Medtronics Interventional Vascular1993-02-12
SCHNEIDER PTCA CATHETER (P880027/S025)Boston Scientific1993-02-12
CCS MODEL 300 PACEMAKER MAESTRO (P890039/S010)Cardiac Control Systems, Inc.1993-02-12
ACS RX STREAK(TM) .010 CORONARY DILATATION CATH. (P810046/S135)Advanced Cardiovascular Systems, Inc.1993-02-11
ACS RX STREAK (TM) & FLOWTRACK DILATION CATHETERS (P810046/S129)Advanced Cardiovascular Systems, Inc.1993-02-11
SIMPSON CORONARY ATHEROCATH(R) SCA-I(TM),SCA-LP(TM (P890043/S013)Abbott Vascular1993-02-11
MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEM (P900061)Medtronic Cardiac Rhythm Disease Management1993-02-11
SCIMED(R) PTCA CATHETER (P860019/S070)Scimed Life Systems, Inc.1993-02-11
GEMNOS(TM) 04 CARDIAC PACEMAKER & SWN 600/C00U02 (P820076/S014)Biotronik, Inc.1993-02-09
GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM) (P910030)Cook, Inc.1993-02-08
SYNCHRONY(R)MODEL 2020T PULSE GEN.,& 3000 PROGRAMM (P880086/S017)ABBOTT MEDICAL1993-02-05
SOLUS(R) II MODELS 2006L,2006T,2007K,2007M/S PULSE (P880086/S016)ABBOTT MEDICAL1993-02-05
DELTA(R) PULSE GENERATOR (P840068/S018)Boston Scientific1993-02-05
SCIMED(R) PTCA CATHETER KING COBRA (TM) (P860019/S055)Scimed Life Systems, Inc.1993-02-05
MODEL 5603,9600 PROGRAMMER NEW SOFTWARE,V4.10UE (P820018/S056)St. Jude Medical, Inc.1993-02-05
SCIMED LONG KING COBRA 30 & 40 PTCA CATHETERS (P860019/S054)Scimed Life Systems, Inc.1993-02-05
AFP CARDIAC PACING SYSTEM (P830045/S038)St. Jude Medical, Inc.1993-02-05
SCIMED(R) ACE,LONGACE (TM)PTCA CATHETER CHANGES (P860019/S065)Scimed Life Systems, Inc.1993-02-05
SCIMED(R) GRAFT ACE(TM) PTCA CATHETER (P860019/S058)Scimed Life Systems, Inc.1993-02-05
HANCOCK MODIFIED ORIFICE BIOPROSTHESIS (P790007/S010)Medtronic Heart Valves1993-02-02
LONG REACH(TM) 30MM PTCA CATHETER (P850021/S020)Abbott Vascular, Inc.1993-01-29
HANCOCK BIOPROSTHESIS MODELS 242,342,343C,342R (P870078/S002)Medtronic, Inc.1993-01-29
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S021)Medtronic Cardiac Surgery1993-01-29
SCIMED ACE(TM) & LONG ACE(TM) PTCA CATHETERS (P860019/S053)Scimed Life Systems, Inc.1993-01-28
AFP CARDIAC PACING SYSTEM (P830045/S041)St. Jude Medical, Inc.1993-01-22
SENSOLOG (R) MODEL 3038 SOFTWARE MODIFICATION (P880006/S016)St. Jude Medical, Inc.1993-01-22
SLINKY(TM),EDGE(TM),QUICK(TM),PTCA CATHETER (P850021/S018)Abbott Vascular, Inc.1993-01-22
SYNERGY(TM)CONV. RAPID EXCHANGE PTCA CATHETER (P840040/S029)Boston Scientific Corp1993-01-12
SIMPSON CORONARY ATHEROCATH(R) SCA-I(TM),SCA-LP(TM (P890043/S016)Abbott Vascular1993-01-12
INTERTACH(R)II MODELS 262-16/262-16R DISCON.TEST (P860007/S010)Boston Scientific1993-01-11
PACESETTER MODEL 3070 & PACE MEDICAL MODEL 4553 (P830045/S032)St. Jude Medical, Inc.1993-01-11
SOLUS(TM) MODEL 2002L & SYNCHRONY II MODEL 2022L (P880086/S010)ABBOTT MEDICAL1993-01-11
SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B (P880006/S009)St. Jude Medical, Inc.1993-01-11
COSMOS(R)II,NOVA(R)II,QUANTUM(R)II, & RX2000(R) (P830026/S055)Boston Scientific1993-01-11
RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS (P910020/S002)Boston Scientific1993-01-11
GELSEAL TM TRIAXIAL VASCULAR GRAFT (P890045)Carbomedics, Inc.1993-01-11
EXCIMER LASER MODEL LAISER II (P900032/S013)Spectranetics Corp.1993-01-08
META III MODEL 1206,1206E,1206M PACING SYSTEMS (P880038/S020)St. Jude Medical, Inc.1993-01-07
MODEL 9600 PROG.,1250H GENERATOR SOFTWARE V4.10UE (P900070/S002)St. Jude Medical, Cardiac Rhythm Management Divisi1993-01-07
SLIDER(TM) STRETCH CORONARY BALL. DILITATION CATH. (P840040/S035)Boston Scientific Corp1992-12-30
NITECH(TM) CORONARY BALLOON DILITATION CATHETER (P840040/S034)Boston Scientific Corp1992-12-30
SCHNEIDER XLP & PICCOLINO PTCA CATHETER CHANGES (P880027/S023)Boston Scientific1992-12-30
COSMOS(R)II,NOVA(R)II,QUANTUM(R)II, & RX2000(R) (P830026/S054)Boston Scientific1992-12-29
MEDTRONIC(R)THRUFLEX(TM) II OVER-THE-WIRE (P870036/S018)Medtronics Interventional Vascular1992-12-29
INTERTACH(R)II & RX2000(R) GRAPHICS PROGRAM MODULE (P860007/S009)Boston Scientific1992-12-29
RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS (P910020/S001)Boston Scientific1992-12-29
MODEL 9760 PROGRAMMING SYSTEM (P890003/S007)Medtronic, Inc.1992-12-29
MEDTRONIC(R)THRUFLEX(TM) II OVER-THE-WIRE (P870036/S017)Medtronics Interventional Vascular1992-12-24
HELIX UPGRADE PTCA DILATATION CATHETERS (P880003/S008)Cordis Corp.1992-12-18
CPI MODEL4262 PACE LEAD ,MODIFY TECH MANUAL (P850089/S024)Medtronic Cardiac Rhythm Disease Management1992-12-17
JJIS PALMAZ(TM) BALLOON-EXPANDABLE STENT (P890017/S002)Cordis US Corporation1992-12-11
COOK BIRD'S NEST VENA CAVA FILTER (P850049/S001)Cook, Inc.1992-12-08
SIMPSON CORONARY ATHEROCATH(R) SCA-I(TM),SCA-LP(TM (P890043/S015)Abbott Vascular1992-12-07
MEDTRONIC (R) ELITE II PULSE GENERATOR (P890003/S016)Medtronic, Inc.1992-12-04
SLIDER(TM)/2.0 MM BALLOON DILATION CATHETER (P840040/S033)Boston Scientific Corp1992-11-20
ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM (P900023)Abiomed Cardiovascular, Inc.1992-11-20
CARBON TIPPED LEAD ALT.PROD.TRAYS (P800041/S012)Pacesetter Systems1992-11-18
SYNCHRONY(R)ALTERNATE PRODUCT TRAY (P880086/S018)ABBOTT MEDICAL1992-11-18
SENSOLOG (R) ALTERNATE PRODUCT TRAY (P880006/S014)St. Jude Medical, Inc.1992-11-18
AFP CARDIAC PACING SYSTEM (P830045/S039)St. Jude Medical, Inc.1992-11-18
MEDTRONIC(R) MODELS 9710/9710A ,MOD.2038 MODIFICAT (P820003/S064)Medtronic Cardiac Rhythm Disease Management1992-11-16
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (22MM) (P790018/S019)Medtronic Cardiac Surgery1992-11-06
CORDIS 3.5MM SOFT-WIRE ORION STEERABLE PTCA CATH. (P890032/S016)Cordis Corp.1992-11-06
MEDTRONIC LEGEND II,MICRO MINIX MODIFICATIONS (P850051/S036)Medtronic, Inc.1992-11-05
ACS RX PERFUSION(TM) CORONARY DILATATION CATH. (P810046/S133)Advanced Cardiovascular Systems, Inc.1992-11-05
MEDTRONIC MODELS ELITE,MINUET,& PRELUDE DR MODIF. (P890003/S018)Medtronic, Inc.1992-11-05
ALTERNATE STERILIZATION/VENTAK(TM)1550,55 PULSE (P830060/S028)Boston Scientific1992-10-30
ACS(R) RX FLOWTRACK(TM) 40 CORONARY DILITATIN CATH (P810046/S118)Advanced Cardiovascular Systems, Inc.1992-10-29
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