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Cardiovascular

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

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RecordFirmDate
SCHNEIDER MONGOOSE(TM) PTCA CATHETER (P880027/S022)Boston Scientific1992-10-29
SJM PYROLYTIC (R) CARBON HEART VALVE HEMODYNAMIC + (P810002/S024)ABBOTT MEDICAL1992-10-27
USCI(R) SOLO(TM) BALL. DIL. CATH. W/PRO/PEL COAT (P790017/S041)Medtronic, Ireland1992-10-20
STRONG SHADOW(TM) CATHETER (P860019/S045)Scimed Life Systems, Inc.1992-10-01
ACS RX STREAK(TM) .014 CORONARY DILATATION CATH. (P810046/S132)Advanced Cardiovascular Systems, Inc.1992-10-01
VENTAK P MODEL 1600 (P890061/S005)Boston Scientific1992-09-24
VENTAK MODELS 1550 AND 1555 (P830060/S032)Boston Scientific1992-09-24
MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM (P890039/S006)Cardiac Control Systems, Inc.1992-09-14
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S020)Medtronic Cardiac Surgery1992-09-03
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S017)Medtronic Cardiac Surgery1992-08-25
MEDTRONIC MODEL 9855 SOFTWARE CHANGE (P890003/S017)Medtronic, Inc.1992-08-18
SYNCHRONY(R) SOFTWARE CHANGE (P880086/S020)ABBOTT MEDICAL1992-08-11
ARZCO OCTAPOLAR ESOPHAGEAL CARDIAC STIMULATORS (P860008/S011)Cardio Command1992-08-06
CCS MODEL 333 PACEMAKER INTRO. 3 NEW MODELS (P890039/S009)Cardiac Control Systems, Inc.1992-08-03
MEDTRONIC(R) CORONARY BALLOON DILITATION CATHETERS (P870036/S016)Medtronics Interventional Vascular1992-08-03
SLIDER(TM) 018 CORONARY BALLOON SLEEVE MODIFI. (P840040/S031)Boston Scientific Corp1992-07-29
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S002)Cordis Corp.1992-07-23
SLIDER(TM) 018 CORONARY BALLOON DILITATION CATH. (P840040/S030)Boston Scientific Corp1992-07-13
HELIX PTCA DILATION CATHETERS AND Y- CONNECTORS (P880003/S009)Cordis Corp.1992-07-13
ACS RX PERFUSION CORON. DILATION CATHETER ADD 2.0 (P810046/S121)Advanced Cardiovascular Systems, Inc.1992-07-10
ACS STACK 40-S(TM) CORONARY DILATATION CATHETER (P810046/S119)Advanced Cardiovascular Systems, Inc.1992-07-10
CORDIS ORION STEERABLE PTCA CATH. W/GLISSADE HYDRO (P890032/S015)Cordis Corp.1992-06-22
MEDTRONIC(R) 18K(TM) OVER-THE-WIRE CORO.BALL.CATH. (P870036/S015)Medtronics Interventional Vascular1992-06-22
MEDTRONIC(R) MODEL 5342 & 5245 PULSE GENERATOR (P820003/S061)Medtronic Cardiac Rhythm Disease Management1992-06-16
RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS (P910020)Boston Scientific1992-06-15
HELIX PTCA DILATATION CATHETER (P880003/S007)Cordis Corp.1992-06-12
MEDTRONIC(R) MODELS 5342 & 5345 TEMP. PULSE GEN. (P820003/S063)Medtronic Cardiac Rhythm Disease Management1992-06-09
NITECH TM 018 PTCA CATHETER (P840040/S028)Boston Scientific Corp1992-05-29
VENTAK P MODEL 1600 (P890061/S003)Boston Scientific1992-05-14
VENTAK MODELS 1550 AND 1555 (P830060/S030)Boston Scientific1992-05-14
ELITE & PRELUDE DR PULSE GENERATORS (P890003/S015)Medtronic, Inc.1992-05-04
MODEL 3038 FUNCTION PACK FOR ASP-II 3003 PROGRAMME (P880006/S013)St. Jude Medical, Inc.1992-04-14
MODEL 3038 FUNCTION PACK FOR APS-II 3003 PROGRAMME (P880086/S015)ABBOTT MEDICAL1992-04-14
MODEL 3038 FUNCTION PACT FOR ASP-II 3003 PROGRAMME (P830045/S037)St. Jude Medical, Inc.1992-04-14
MEDTRONIC LEGEND,LEGEND II & TRIUMPH VR PULSE GEN (P850051/S035)Medtronic, Inc.1992-04-10
MODEL 7074, 7075 AND 7077 ELITE(TM) PULSE GENERATO (P890003/S014)Medtronic, Inc.1992-04-10
CPI DEXATIP(TM) MODEL 4262 TRANSVENOUS PACING LEAD (P850089/S023)Medtronic Cardiac Rhythm Disease Management1992-04-09
ACS CORONARY DILATATION CATHETERS (P810046/S117)Advanced Cardiovascular Systems, Inc.1992-04-09
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S013)Cordis Corp.1992-04-03
MODEL 9760 PROGRAMMING SYSTEM (P890003/S012)Medtronic, Inc.1992-04-03
CHANGES TO ACS(R) RX STREAK(TM).014 & .010 CATH. (P810046/S123)Advanced Cardiovascular Systems, Inc.1992-03-24
ACS (R) RX STREAK (TM)CORONARY DILATION CATHETER (P810046/S116)Advanced Cardiovascular Systems, Inc.1992-03-24
MODEL 370-08 WAND EXTENSION FOR COSMOS(R)RX2000 (P830026/S053)Boston Scientific1992-03-20
SIMPSON CORONARY ATHEROCATH(R) SCA-EX DEVICE (P890043/S012)Abbott Vascular1992-03-20
SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S015)Trimedyne, Inc.1992-03-20
MODELS 7107,7108 MINUET PULSE GENERATORS (P890003/S011)Medtronic, Inc.1992-03-20
CHORUS(R) MODEL 6004&6034 DDD MODEL CPRI MODEL P2A (P900022/S001)MicroPort CRM USA, Inc.1992-03-18
CHORUS(R) MODEL 6001,3,33 DDD MODEL CPRI MODEL P2A (P900022/S003)MicroPort CRM USA, Inc.1992-03-13
REACH(TM).14 PTCA CATH.1.5MM & 4.0MM BALL. SIZES (P850021/S019)Abbott Vascular, Inc.1992-03-13
CAPSURE(R) SP MODEL 5024M TRANSVENOUS PACING LEAD (P850089/S018)Medtronic Cardiac Rhythm Disease Management1992-03-05
ACS RX ALPHA CORONARY DILATION CATHETERS (P810046/S110)Advanced Cardiovascular Systems, Inc.1992-03-04
AMERICAN EDWARDS LABS HYBRID PTCA CATHETER (P850021/S015)Abbott Vascular, Inc.1992-03-04
INTERTACH & INTERTACH II PULSE GENERATORS (P860007/S008)Boston Scientific1992-03-03
META II MODEL 1204H CARDIAC PACING SYSTEM (P880038/S021)St. Jude Medical, Inc.1992-02-28
MODEL 7074, 7075 AND 7077 ELITE(TM) PULSE GENERATO (P890003/S013)Medtronic, Inc.1992-02-28
SENSOLOG(R)III & DIALOG(R)II PULSE GENERATORS (P880006/S012)St. Jude Medical, Inc.1992-02-25
SCIMED COBRA 10(TM) CATHETER (P860019/S042)Scimed Life Systems, Inc.1992-02-25
MEDTRONIC(R) HALL PROSTHETIC HEART VALVE (P790018/S018)Medtronic Cardiac Surgery1992-02-25
MODEL 283 PULSE GENERATOR & MODEL 370 PROGRAMMER (P830045/S036)St. Jude Medical, Inc.1992-02-25
PTCA CATHETER EXTENSION OF SILICONE COATING (P840040/S027)Boston Scientific Corp1992-02-25
SCIMED ACE(TM)&LONG ACE(TM)PTCA CATHETERS (P860019/S048)Scimed Life Systems, Inc.1992-02-14
MEDTRONIC(R) CAPSURE(R)&CAPSURE(R) SP PACING LEADS (P850089/S020)Medtronic Cardiac Rhythm Disease Management1992-02-14
CAPSURE(R) AND CAPSURE(R) SP PACING LEADS (P830061/S017)Medtronic Cardiac Rhythm Disease Management1992-02-14
SLINKY(TM) PTCA CATHETER (P850021/S017)Abbott Vascular, Inc.1992-02-14
CORDIS 3.5 MM SOFT-WIRE ORION STEERABLE PTCA BALL. (P890032/S007)Cordis Corp.1992-02-14
MEDTRONIC(R) 14K OVER THE WIRE CORONARY BALL.CATH. (P870036/S014)Medtronics Interventional Vascular1992-02-13
ACS XT 600 CORONARY DILITATION CATHETER (P810046/S106)Advanced Cardiovascular Systems, Inc.1992-02-10
VENTAK P MODELS 1600&1610 & SOFTWARE MODULE 2830 (P890061/S001)Boston Scientific1992-02-10
MEDTRONIC(R) MODEL 7000 VERSATRAX(R) PULSE GEN. (P820003/S062)Medtronic Cardiac Rhythm Disease Management1992-02-07
PMS-600 PROGRAMMER (P820076/S013)Biotronik, Inc.1992-02-07
ACS SLALOM(TM) CORONARY DILATATION CATHETER (P810046/S113)Advanced Cardiovascular Systems, Inc.1992-02-07
ACS SLALOM(TM) CORONARY DILATATION CATHETER (P810046/S112)Advanced Cardiovascular Systems, Inc.1992-02-04
AIS EXIMER LASER ANGIOPLASTY (P900032)Spectranetics Corp.1992-01-31
META DDDR PACING SYSTEM (P900070)St. Jude Medical, Cardiac Rhythm Management Divisi1992-01-30
SCHNEIDER MAGNARAIL (PTCA) CATHETER (P880027/S019)Boston Scientific1992-01-30
SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER (P870043/S014)Trimedyne, Inc.1992-01-29
SCHNEIDER MICROSOFTRAC(R) PTCA CATHETER (P880027/S020)Boston Scientific1992-01-24
SCHNEIDER XLP(TM)30 PTCA CATHETER (P880027/S021)Boston Scientific1992-01-24
SCHNEIDER MONORAIL PICCOLINO(R) FORTE PTCA CATH. (P880027/S017)Boston Scientific1992-01-24
MODEL 282-04Y NOVA(TM)II (P830026/S052)Boston Scientific1992-01-21
POLYSAFE(TM) A-TRACK(TM) MODEL AT-332 ENDOCARDIAL (P890039/S001)Cardiac Control Systems, Inc.1992-01-21
META II MODEL 1204 CARDIAC PACING SYSTEM (P880038/S019)St. Jude Medical, Inc.1992-01-21
MAESTRO(R) SAVVI(TM) SERIES 300 VDD PACING SYSTEM (P890039/S003)Cardiac Control Systems, Inc.1992-01-21
HARTZLER ACX II(R) CORONARY DILATATION CATHETER (P810046/S104)Advanced Cardiovascular Systems, Inc.1992-01-17
MODEL 282-04R NOVA(TM)II (P830026/S051)Boston Scientific1992-01-17
ACS CORONARY BALLOON DILITATION CATHETER (P810046/S114)Advanced Cardiovascular Systems, Inc.1992-01-17
ACS SLALOM(TM) CORONARY DILATATION CATHETER (P810046/S111)Advanced Cardiovascular Systems, Inc.1992-01-16
SIMPSON CORONARY ATHEROCATH(R) SCA-I(TM),SCA-LP(TM (P890043/S014)Abbott Vascular1992-01-16
THE SHADOW(TM) P-14 PTCA CATHETER (P860019/S050)Scimed Life Systems, Inc.1992-01-16
ACS (R) RX STREAK (TM)CORONARY DILATION CATHETER (P810046/S115)Advanced Cardiovascular Systems, Inc.1992-01-16
SCIMED PTCA CATHETER (TRAPPER(TM)) (P860019/S051)Scimed Life Systems, Inc.1992-01-16
SJM AORTIC VALVED GRAFT (AVG) PROSTHESIS (P810002/S022)ABBOTT MEDICAL1992-01-09
REACH(TM).14 PTCA CATHETER (P850021/S016)Abbott Vascular, Inc.1992-01-07
ACS, OMEGA DILITATION CATHETER (P810046/S102)Advanced Cardiovascular Systems, Inc.1992-01-02
AID (R) B/BR HIGH VOLTAGE CABLES FOR ECD SYSTEMS (P830060/S029)Boston Scientific1991-12-26
MODEL 3037A FUNCTION PACK (P830045/S034)St. Jude Medical, Inc.1991-12-24
MODEL 3037A FUNCTION PACK (P880086/S012)ABBOTT MEDICAL1991-12-24
MODEL 3037A FUNCTION PACK (P880006/S011)St. Jude Medical, Inc.1991-12-24
SCIMED COBRA 14 CATHETER (P860019/S047)Scimed Life Systems, Inc.1991-12-20
CAPSURE(R) MODEL 5023M,5024M PACING LEADS (P850089/S017)Medtronic Cardiac Rhythm Disease Management1991-12-20
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