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Cardiovascular

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

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RecordFirmDate
Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR POT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-I CONNECTOR PORT PIN PLUG KIT, (P920015/S113)Medtronic, Inc.2013-07-23
CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD (P850089/S098)Medtronic Cardiac Rhythm Disease Management2013-07-23
CAPSURE EPICARDIAL PACING LEAD (P950024/S050)Medtronic, Inc.2013-07-23
ADHESIVE, CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELENCE PS+LEAD (P830061/S093)Medtronic Cardiac Rhythm Disease Management2013-07-23
ADAPTA, VERSA, SENSIA IPG (P980035/S327)Medtronic, Inc.2013-07-23
ATTAIN ABILITY LEAD (P080006/S054)Medtronic, Inc.2013-07-23
CELSIUS CATHETER, CELSIUS RMT CATHETER, EZ STEER DS CATHETER, DEFLECTABLE DIAGNOSTIC/ABLATION (P950005/S042)Biosense Webster, Inc.2013-07-22
NAVISTAR CATHETER, NAVISTAR RMT CATHETER, EZ STEER NAY CATHETER, BIOSENSE WEBSTER CABLES (P990025/S035)Biosense Webster, Inc.2013-07-22
EDWARDS SAPIEN TRANSCATETER HEART VALVE AN TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S020)Edwards Lifesciences, LLC2013-07-22
NAVISTAR THERMOCOOL CATHETER, NAVISTAR RMT THERMOCOOL CATHETER, EZ STEER (P040036/S033)Biosense Webster, Inc.2013-07-22
LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S042)Zoll Manufacturing Corporation2013-07-22
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S034)Edwards Lifesciences, LLC2013-07-22
CELSIUS DS CATHETER, NAVISTAR DS CATHETER, NAVISTAR RMT DS CATHETER, EZ STEER NAY DS (P010068/S032)Biosense Webster, Inc.2013-07-22
MYNX VASCULAR CLOSURE DEVICE (P040044/S045)Cordis US Corporation2013-07-22
BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II XP TEMPERATURE ABLATION CATHETER, BLAZER PRIME HTD TEMPERATURE ABLATI (P920047/S058)Boston Scientific Corp2013-07-22
CELSIUS THERMOCOOL CATHETER, CELSIUS RMT THERMOCOOL CATHETER, CELSIUS RMT THERMOCOOL (P030031/S050)Biosense Webster, Inc.2013-07-22
ZILVER PTX DRUG ELUTING PERIPHERAL STENT (P100022/S006)Cook Ireland, Ltd.2013-07-19
WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S046)Boston Scientific Corp2013-07-18
AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE (P110032/S005)Lombard Medical Limited2013-07-18
LIVEWARE TC ABLATION CATHETER (P960016/S042)St Jude Medical2013-07-18
CAROTID WALLSTENT MONORAIL (P050019/S016)Boston Scientific Corp2013-07-18
EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S025)Boston Scientific Corporation2013-07-18
WALLSTENT (VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S035)Boston Scientific Corporation2013-07-18
GORE HELEX SEPTAL OCCLUDER (P050006/S035)W. L. Gore & Associates, Inc.2013-07-17
SMARTABLATE SYSTEM-SMARTABLATE IRRIGATION PUMP KIT (P990071/S023)Biosense Webster, Inc.2013-07-17
ADAPTA, VERSA, SENSIA IPG (P980035/S326)Medtronic, Inc.2013-07-17
RELIANCE IS-1/DF-1,RELIANCE 4-SITE PASSIVE FIXATION LEADS (P910073/S118)Boston Scientific2013-07-16
ADVISA DR IPG,ADVISA DR MRI IPG (P980035/S336)Medtronic, Inc.2013-07-16
CARPENTIER-EDWARDS BIOSPROSTHETIC PULMONIC VALVED CONDUIT (P870056/S060)Edwards Lifesciences, LLC2013-07-16
THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S056)Thoratec Laboratories Corp.2013-07-16
CONSULTA CRT-P,SYNCRA CRT-P (P010015/S206)Medtronic, Inc.2013-07-16
CONSULTA CRT-P, SYNCRA CRT-P (P010015/S201)Medtronic, Inc.2013-07-15
CARELINK MONITORS, CARELINK EXPRESS MONITIORS, CARDIOSIGHT READERS, REVEAL DX, REVEAL XT (P890003/S277)Medtronic, Inc.2013-07-15
CONSULTA CRT D,MAXIMO II CRT-D,CONCERTO II CRT-D,CONCERTO CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA XT CRT-D,VIVA S (P010031/S376)Medtronic Cardiac Rhythm Disease Management2013-07-15
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S043)Abbott Vascular2013-07-15
VIRTUOSO DR,VIRTUOSO VR,SECURA DR, MAXIMO II DR,VIRTUOSO II DR,SECURA VR,MAXIMO II VR,VIRTUOSO II VR,PROTECTA XT DR (P980016/S416)Medtronic Cardiac Rhythm Disease Management2013-07-15
ADVISA, ENRHYTHM MRI (P980035/S325)Medtronic, Inc.2013-07-15
PROMUS ELEMENT PLUS EVEROLIMUS PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S050)Boston Scientific Corp2013-07-15
REVO MRI (P090013/S098)Medtronic, Inc.2013-07-15
RENAMIC (P950037/S124)Biotronik, Inc.2013-07-12
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICDO) SYSTEM (P110042/S010)Boston Scientific Corporation2013-07-12
LIFESTENT VASCULAR STENT SYSTEMS (P070014/S039)Bard Peripheral Vascular, Inc.2013-07-12
TRANSCATHER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S019)Edwards Lifesciences, LLC2013-07-11
TRANSCATHER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S033)Edwards Lifesciences, LLC2013-07-11
GORE TAG THORACIC AAA ENDOPROSTHESIS (P040043/S054)W. L. Gore & Associates, Inc.2013-07-11
GORE EXCUDER AAA EDOPROSTHESIS (P020004/S083)W. L. Gore & Associates, Inc.2013-07-11
GORE TAG THORACIC ENDOPROSTHESIS (P040043/S055)W. L. Gore & Associates, Inc.2013-07-10
ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P060033/S077)Medtronic, Inc.2013-07-10
GORE EXCLUDER AAA ENDOPROSTHESIS (P020004/S084)W. L. Gore & Associates, Inc.2013-07-10
RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM (P110013/S014)Medtronic Vascular2013-07-10
RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM (P110038/S002)Bolton Medical, Inc.2013-07-10
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM. (P900056/S124)Boston Scientific Corp2013-07-10
WALLSTENT RP ENDOPROSTHESIS LLIAC (P940019/S039)Boston Scientific Scimed, Inc.2013-07-09
WALLSTENT RP ENDOPROSTHESIS TIPS (P930031/S045)Boston Scientific Corp2013-07-09
EXPRESS MONORAIL AND OTW CORONARY STENT SYSTEM (P020009/S108)Boston Scientific Scimed, Inc.2013-07-09
CORONARY FLEXTOME CUTTING BALLON (P950020/S063)Boston Scientific Corp2013-07-09
EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S024)Boston Scientific Corporation2013-07-09
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S015)Boston Scientific Corp2013-07-09
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S055)Boston Scientific Corp2013-07-09
WALLSTENT RP ENDOPROSTHESIS VENOUS (P980033/S034)Boston Scientific Corporation2013-07-09
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S047)Boston Scientific Corp2013-07-09
ION (TAXUS ELEMENT CORONARY STENT SYSTEM (P100023/S074)Boston Scientific Corp2013-07-09
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S016)Boston Scientific Corp2013-07-09
VERIFLEX (LIBERTE) CORONARY STENT SYSTEM (P040016/S114)Boston Scientific Scimed, Inc.2013-07-09
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (P060008/S104)Boston Scientific Corp2013-07-09
GORE HELEX SEPTAL OCCLUDER (P050006/S034)W. L. Gore & Associates, Inc.2013-07-05
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES (P110021/S017)Edwards Lifesciences, LLC2013-07-03
ADAPTA, VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG AND RELIA IPG (P980035/S333)Medtronic, Inc.2013-07-03
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P100041/S032)Edwards Lifesciences, LLC2013-07-03
ADAPTA,VERSA,SENSIA IPG (P980035/S332)Medtronic, Inc.2013-07-03
EDWARDS SAPIEN TRANSCATHETER HEART VALVE (P110021/S018)Edwards Lifesciences, LLC2013-07-03
HEART WARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM (P100047/S022)Medtronic2013-07-03
EVERA S DR ICD, EVER S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA IC (P980016/S422)Medtronic Cardiac Rhythm Disease Management2013-07-03
CAPSUREFIX MRI SURESCAN LEAD (P090013/S103)Medtronic, Inc.2013-07-03
COGNIS, INCEPTA, ENERGEN, PUNCTUA (P010012/S331)Boston Scientific Corp2013-07-03
BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, VIVA S CRT-D, VIVA XT CRT-D (P010031/S383)Medtronic Cardiac Rhythm Disease Management2013-07-03
TELIGEN, INCEPTA, ENERGEN, PUNCTUA (P960040/S296)Boston Scientific2013-07-03
INVIVE, INTUA (P030005/S100)Guidant Corp.2013-07-03
CAPSUREFIX NOVUS LEAD (P930039/S092)Medtronic, Inc.2013-07-03
CAPSURE SENSE BIPOLAR LEADS (P830061/S096)Medtronic Cardiac Rhythm Disease Management2013-07-03
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES (P100041/S031)Edwards Lifesciences, LLC2013-07-03
REVO MRI IPG (P090013/S104)Medtronic, Inc.2013-07-03
ADVANTIO, INGENIO, VITALIO, AND FORMIO (N970003/S153)Boston Scientific Corp2013-07-03
BRAD E-LUMINEXX VASCULAR STENT SYSTEM (P080007/S017)Bard Peripheral Vascular, Inc.2013-07-02
RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM (P110013/S017)Medtronic Vascular2013-07-02
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S015)Boston Scientific Corp2013-07-02
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSAPICAL AND TRANSFEMORAL ACCESSORIES (P110021/S004)Edwards Lifesciences, LLC2013-07-02
ANGIO-SEAL VASCULAR CLOSURE DEVICE (P930038/S071)Terumo Medical Corporation2013-07-01
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION SV EVEROLIMUS ELUTING CORONARY STENT SYSTEM (P110019/S039)Abbott Vascular2013-06-28
FLEXTONE CUTTING BALLOON, H7493BM3XXXXX, H749CBO3XXXXX (P950020/S055)Boston Scientific Corp2013-06-28
ST. JUDE MEDICAL MECHANICAL HEART VALVE (P810002/S086)ABBOTT MEDICAL2013-06-28
OPEN PIVOT HEART VALVE & OPEN PIVOTAORTIC VALVED GRAFT (P990046/S028)Medtronic Ats Medical, Inc.2013-06-28
VITATRON C20 SR IPG,VITATRON C60 DR IPG,VITATRON T20 SR IPG (P990001/S114)Medtronic, Inc.2013-06-27
ADAPTA,ADAPTAL,ADAPTA S,SENSIA L,SENSIA,VERSA IPG,RELIA IPG,SIGMA DR IPG,SIGMA S IPG (P980035/S331)Medtronic, Inc.2013-06-27
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V EECSS,XIENCE V) (P070015/S112)Abbott Vascular, Inc.2013-06-27
PRODIGY IPG (P890003/S279)Medtronic, Inc.2013-06-27
XIENCE PRIME EECSS (XIENCE PRIME AND XIENCE PRIME LONG LENGTHS [LL]) (P110019/S049)Abbott Vascular2013-06-27
WALLSTENT LLIAC ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P940019/S038)Boston Scientific Scimed, Inc.2013-06-26
REVO MRI IPG (P090013/S102)Medtronic, Inc.2013-06-26
ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM (P110028/S008)Abbott Vascular, Inc.2013-06-26
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Every clearance here is in the API, with alerts when new ones post.