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Cardiovascular

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

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RecordFirmDate
LifeStent Vascular Stent System (P070014/S065)Bard Peripheral Vascular, Inc.2023-07-27
Cordis® S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent System, Cordis® S.M.A.R.T. RADIANZ Vascular Stent System (P120002/S024)Cordis US Corporation2023-07-27
Express® SD Renal Monorail Premounted Stent System (P060006/S107)Boston Scientific Corp2023-07-27
`Cordis® S.M.A.R.T.® CONTROL Vascular Stent System, Cordis® S.M.A.R.T. RADIANZ TM Vascular Stent System (P020036/S049)Cordis US Corporation2023-07-27
Blazer Open-Irrigated Ablation Catheter (P150005/S078)Boston Scientific Corp2023-07-27
Chilli Cooled Rf Ablation System (P980003/S096)Boston Scientific Corp2023-07-27
Rotablator Rotational Atherectomy System (P900056/S209)Boston Scientific Corp2023-07-27
PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System (P110010/S211)Boston Scientific Corp2023-07-27
Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S140)Boston Scientific2023-07-27
Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S022)Boston Scientific Corporation2023-07-27
Blazer II Cardiac Ablation System and Cable (P920047/S132)Boston Scientific Corp2023-07-27
Melody Transcatheter Pulmonary Valve System (P140017/S024)Medtronic, Inc.2023-07-27
INSPIRIS RESILIA Aortic Valve, Model 11500A (P150048/S073)Edwards Lifesciences, LLC2023-07-27
Adaptor Assembly Cable, Analzer Cable, CareLink Encore Programmer, CareLink SmartSync Device Manager Patient Connector, (P890003/S462)Medtronic, Inc.2023-07-26
Patient Cable (P820003/S140)Medtronic Cardiac Rhythm Disease Management2023-07-26
CardioMEMS HF System (P100045/S068)ABBOTT MEDICAL2023-07-26
VenaSeal Closure System (P140018/S037)Medtronic Vascular, Inc.2023-07-25
Medtronic CoreValve™ Evolut™ R Transcatheter Aortic Valve, Medtronic CoreValve™ Evolut™ Pro Transcatheter Aortic Valve, (P130021/S141)Medtronic, Inc.2023-07-25
Accessory, Cap, Accessory, Plug (P910077/S192)Boston Scientific2023-07-21
FINELINE® II Sterox, FINELINE® II EZ Sterox, ACC SUP STABLZR 6220 US, ACC SUP STABLZR 6221 US (P960004/S105)Boston Scientific2023-07-21
DiamondTemp™ Unidirectional Ablation Catheter, Small Curve, DiamondTemp™ Unidirectional Ablation Catheter, Large Curve, (P200028/S020)Medtronic, Inc.2023-07-21
ORIGEN™ MINI ICD VR, ORIGEN™ MINI ICD DR, INOGEN™ MINI ICD VR, INOGEN™ MINI ICD DR, DYNAGEN™ MINI ICD VR, DYNAGEN™ MINI (P960040/S496)Boston Scientific2023-07-21
Accessory, Wrench (P930035/S034)Boston Scientific2023-07-21
OPTIMIZER Smart and Smart Mini (P180036/S019)Impulse Dynamics (Usa), Inc.2023-07-21
GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S159)W. L. Gore & Associates, Inc.2023-07-21
EMBLEM™ S-ICD, EMBLEM™ MRI S-ICD (P110042/S188)Boston Scientific Corporation2023-07-21
VALITUDE™ CRT-P, VALITUDE™ X4 CRT-P, VISIONIST™ CRT-P, VISIONIST™ X4 CRT-P (P030005/S232)Guidant Corp.2023-07-21
- ESSENTIO™ SR, ESSENTIO™ DR, SSENTIO™ EL DR, PROPONENT™ SR, PROPONENT™ DR, PROPONENT™ EL DR, ACCOLADE™ SR, ACCOLADE™ DR (N970003/S287)Boston Scientific Corp2023-07-21
GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S098)W. L. Gore & Associates, Inc.2023-07-21
Lead Repair Kit, ENDOTAK RELIANCE® S, ENDOTAK RELIANCE®, ENDOTAK RELIANCE® SG, ENDOTAK RELIANCE® G, RELIANCE 4-FRONT™, A (P910073/S173)Boston Scientific2023-07-21
ACUITY™ Spiral, Accessory, Slit Suture Sleeve, ACUITY™ X4 Straight, ACUITY™ X4 Spiral S, ACUITY™ X4 Spiral L, Slit Sutu (P010012/S575)Boston Scientific Corp2023-07-21
PALMAZ MULLINS XD Pulmonary Stent (P220004)Cordis US Corp2023-07-21
Accessory, Stabilizer (P960006/S056)Boston Scientific2023-07-21
ACUITY Stylet, Straight 0.013, 45cm, ACUITY Stylet, Straight 0.013, 52cm, ACUITY Stylet, Straight 0.013, 59cm, ACUITY St (P150012/S148)Boston Scientific2023-07-21
Accessory, Cap, Accessory, Sleeve, Accessory, Wrench Torque BI (P830060/S089)Boston Scientific2023-07-21
ENROUTE Transcarotid Stent System (P140026/S027)Boston Scientific Corporation2023-07-20
Astron Pulsar, Pulsar-18, Pulsar-18 T3 (P160025/S017)Biotronik AG2023-07-20
S-ICD GEN 2 A209, S-ICD EMBLEM MRI A219 (P110042/S187)Boston Scientific Corporation2023-07-20
ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL ICD VR (P960040/S495)Boston Scientific2023-07-20
EluNIR™ Ridaforolimus Eluting Coronary Stent System (P170008/S045)Medinol, Ltd.2023-07-20
Astron (P140030/S016)Biotronik AG2023-07-20
Xience Skypoint Everolimus Eluting Coronary Stent System (P110019/S125)Abbott Vascular2023-07-20
QDOT MICRO CATHETER, nGEN RF Generator, TX eco Cable, TX eco EXT Cable (P210027/S002)Biosense Webster, Inc.2023-07-20
MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CRT-D, RESONATE CRT- (P010012/S574)Boston Scientific Corp2023-07-20
DiamondTemp Ablation System (P200028/S021)Medtronic, Inc.2023-07-19
Neutrino™ NxT HF, Avant™ HF, Gallant ™ HF, Entrant™ HF (P030054/S409)ABBOTT MEDICAL2023-07-19
CardioMEMSTM HF System (P100045/S067)ABBOTT MEDICAL2023-07-19
Medtronic Open Pivot Aortic Valved Graft (AVG) (P990046/S066)Medtronic Ats Medical, Inc.2023-07-19
GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S100)W. L. Gore & Associates, Inc.2023-07-18
THERMOCOOL SMARTTOUCH® Catheter (P030031/S126)Biosense Webster, Inc.2023-07-18
GORE® VIABAHN® Endoprosthesis (P040037/S161)W. L. Gore & Associates, Inc.2023-07-18
Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S862)Medtronic Cardiac Rhythm Disease Management2023-07-17
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (P010031/S828)Medtronic Cardiac Rhythm Disease Management2023-07-17
ROTAPRO Rotational Atherectomy System (P900056/S208)Boston Scientific Corp2023-07-17
VESTA/GUARDIO Charger (P180036/S018)Impulse Dynamics (Usa), Inc.2023-07-17
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S523)Medtronic, Inc.2023-07-17
IntellaNav MiFi Open-Irrigated (OI) Ablation Catheter (P150005/S076)Boston Scientific Corp2023-07-17
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S753)Medtronic, Inc.2023-07-17
Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S175)Medtronic, Inc.2023-07-17
XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S (P110019/S127)Abbott Vascular2023-07-14
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S754)Medtronic, Inc.2023-07-13
Mynx Control Vascular Control Device (5F, 6F/7F) (P040044/S094)Cordis US Corporation2023-07-13
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S040)W. L. Gore & Associates, Inc.2023-07-13
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S522)Medtronic, Inc.2023-07-13
KONECT RESILIA Aortic Valved Conduit (P150048/S072)Edwards Lifesciences, LLC2023-07-12
iCast Covered Stent System (P120003/S001)Atrium Medical Corp.2023-07-12
CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S217)Medtronic Cardiac Rhythm Disease Management2023-07-11
Sprint Quattro Lead (P920015/S279)Medtronic, Inc.2023-07-11
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S253)Medtronic, Inc.2023-07-11
CapSureFix MRI Lead (P090013/S328)Medtronic, Inc.2023-07-11
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead, (P080006/S177)Medtronic, Inc.2023-07-11
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S463)Medtronic, Inc.2023-07-11
Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S176)Medtronic, Inc.2023-07-11
CapSure Epicardial Pacing Lead (P950024/S107)Medtronic, Inc.2023-07-11
Implantable Cardioverter Defibrillators (ICDs) (P960040/S494)Boston Scientific2023-07-07
HeartWare® Ventricular Assist System (P100047/S212)Medtronic2023-07-07
Myopore® Sutureless Myocardial Pacing Lead (P130012/S014)Great Batch Medical2023-07-07
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S186)Boston Scientific Corporation2023-07-07
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) (P010012/S573)Boston Scientific Corp2023-07-07
AngioSculpt RX PTCA Scoring Balloon Catheter, AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S032)Spectranetics Corp.2023-07-07
Edwards SAPIEN 3 Transcatheter Heart Valves, Edwards SAPIEN 3 Ultra Transcatheter Heart Valves, Edwards SAPIEN 3 Ultra R (P140031/S159)Edwards Lifesciences, LLC2023-07-06
FINELINE® II Sterox, FINELINE® II EZ Sterox (P960004/S103)Boston Scientific2023-07-06
EMBLEM™ S-ICD, (P110042/S185)Boston Scientific Corporation2023-07-06
SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S064)Syncardia Systems, LLC2023-07-06
ACUITY™ Spiral, ACUITY™ X4 Straight, ACUITY™ X4 Spiral (P010012/S572)Boston Scientific Corp2023-07-06
PASCAL Precision Transcatheter Valve Repair System (P220003/S007)Edwards Lifesciences, LLC2023-07-06
ENDOTAK RELIANCE®, RELIANCE 4-FRONT™ (P910073/S172)Boston Scientific2023-07-06
INGEVITY™ MRI, INGEVITY™+ (P150012/S147)Boston Scientific2023-07-06
Edwards SAPIEN 3 Transcatheter Heart Valves (P200015/S042)Edwards Lifesciences, LLC2023-07-06
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S041)W. L. Gore & Associates, Inc.2023-07-05
GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S160)W. L. Gore & Associates, Inc.2023-07-05
Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S852)Medtronic Cardiac Rhythm Disease Management2023-07-05
GORE® TAG® Thoracic Branch Endoprosthesis (Side Branch Component only) (P210032/S010)W. L. Gore & Associates, Inc.2023-07-05
GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S099)W. L. Gore & Associates, Inc.2023-07-05
Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (P010031/S818)Medtronic Cardiac Rhythm Disease Management2023-07-05
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR (P980035/S752)Medtronic, Inc.2023-07-03
HeartMate 3 Left Ventricular Assist System (P160054/S051)ABBOTT MEDICAL2023-07-03
LIFEPAK® 1000 Defibrillator (P160026/S039)Physio-Control, Inc.2023-07-03
EXCOR® Pediatric Ventricular Assist Device (P160035/S033)Berlin Heart, Inc.2023-06-30
LifeVest Wearable Defibrillator (P010030/S162)Zoll Manufacturing Corporation2023-06-30
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