Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- DQDStethoscope, Electronic2Product Code
- DQECatheter, Oximeter, Fiber-Optic2Product Code
- DQGMicrosphere, Trace3Product Code
- DQKComputer, Diagnostic, Programmable2Product Code
- DQOCatheter, Intravascular, Diagnostic2Product Code
- DQPKit, Balloon Repair, Catheter3Product Code
- DQRCannula, Catheter2Product Code
- DQTOccluder, Catheter Tip2Product Code
- DQXWire, Guide, Catheter2Product Code
- DQYCatheter, Percutaneous2Product Code
- DRACatheter, Steerable2Product Code
- DRBStylet, Catheter2Product Code
- DRCTrocar2Product Code
- DREDilator, Vessel, For Percutaneous Catheterization2Product Code
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording2Product Code
- DSIDetector And Alarm, Arrhythmia2Product Code
- DSJAlarm, Blood-Pressure2Product Code
- DSKComputer, Blood-Pressure2Product Code
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function2Product Code
- DXLInjector, Indicator2Product Code
- DXMDensitometer2Product Code
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive2Product Code
- DXQBlood Pressure Cuff2Product Code
- DXWSystem, Phonocatheter, Intracavitary2Product Code
- DXXSystem, Catheter Control, Steerable2Product Code
- DYBIntroducer, Catheter2Product Code
- DYGCatheter, Flow Directed2Product Code
- JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)2Product Code
- KRACatheter, Continuous Flush2Product Code
- KRBProbe, Thermodilution2Product Code
- KRKManometer, Blood-Pressure, Venous2Product Code
- LDEStethoscope, Manual1Product Code
- LITCatheter, Angioplasty, Peripheral, Transluminal2Product Code
- K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter2Cleared 510(K)
- K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter2Cleared 510(K)
- K241040Amethyst HP PTA OTW 0.035 Catheter2Cleared 510(K)
- K242419018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter2Cleared 510(K)
- K241740Finesse Injectable™ PTA Balloon Dilatation Catheter2Cleared 510(K)
- K241711Oscar Peripheral Multifunctional Catheter system2Cleared 510(K)
- K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031406020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031408020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031410020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031412020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031415020); Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H7493903142Cleared 510(K)
- K241025JADE PLUS PTA Balloon Dilatation Catheter2Cleared 510(K)
- K231402HP PTA Balloon Dilatation Catheter2Cleared 510(K)
- K230263Finesse™ Injectable PTA Balloon Dilatation Catheter2Cleared 510(K)
- K214009D·Kaptain PTA High Pressure Balloon Dilatation Catheter2Cleared 510(K)
- K230191Arise™ UHP Dilatation Catheter2Cleared 510(K)
- K222065Passeo-35 Xeo Peripheral Dilatation Catheter2Cleared 510(K)
- K223177Highlander™ 014 PTA Balloon Dilatation Catheter2Cleared 510(K)
- K221245PTA Balloon Dilatation Catheter2Cleared 510(K)
- K221414ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter2Cleared 510(K)
- K221832SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter2Cleared 510(K)
- K212215Tiche PTA Balloon Dilatation Catheter2Cleared 510(K)
- K214038Oscar Peripheral Multifunctional Catheter system2Cleared 510(K)
- K220410Ebony HP PTA OTW 0.035 Catheter2Cleared 510(K)
- K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection2Cleared 510(K)
- K221057Viatrac 14 Plus Peripheral Dilatation Catheter2Cleared 510(K)
- K213631Chocolate PTA Balloon Catheter2Cleared 510(K)
- K201246PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)2Cleared 510(K)
- K211044Sublime Radial Access 018 RX Dilatation Catheter2Cleared 510(K)
- K210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter2Cleared 510(K)
- K202231JADE2Cleared 510(K)
- K202800Pacific Plus PTA Catheter2Cleared 510(K)
- K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter2Cleared 510(K)
- K201170Athletis PTA Balloon Dilatation Catheter2Cleared 510(K)
- K201333SABER .035 PTA Dilatation Catheter2Cleared 510(K)
- K201794Jade2Cleared 510(K)
- K192399Infinity Angioplasty Balloon Catheter2Cleared 510(K)
- K200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter2Cleared 510(K)
- K191275All’InCath 035M PTA Balloon Dilatation Catheter2Cleared 510(K)
- K192907Advocate PTA Catheter2Cleared 510(K)
- K190037Cronus HP PTA Balloon Catheter2Cleared 510(K)
- K192318Ultraverse 014 and 018 PTA Balloon Dilatation Catheters2Cleared 510(K)
- K190753EverCrossTM 0.035 OTW PTA Dilatation Catheter2Cleared 510(K)
- K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection2Cleared 510(K)
- K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)2Cleared 510(K)
- K181323Atlas Gold PTA Dilatation Catheter2Cleared 510(K)
- K180007018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter2Cleared 510(K)
- K173515Admiral Xtreme2Cleared 510(K)
- K173894Jade PTA Balloon Dilatation Catheter2Cleared 510(K)
- K172494PROTEUS PTA Balloon Catheter with Embolic Capture Feature2Cleared 510(K)
- K173621Advocate PTA Catheter2Cleared 510(K)
- K171251014 Hydrophilic Coated PTA Balloon Dilatation Catheter2Cleared 510(K)
- K172033Pirouette High Pressure (HP)2Cleared 510(K)
- K171290Vela RX PTA Balloon Dilatation Catheter2Cleared 510(K)
- K170635Chameleon PTA Balloon Catheter2Cleared 510(K)
- K170193Advance 14LP Low Profile PTA Balloon Dilatation Catheter2Cleared 510(K)
- K163231Chameleon PTA Balloon Catheter2Cleared 510(K)
- K163479R2P Metacross RX2Cleared 510(K)
- K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter2Cleared 510(K)
- K162316Pirouette 0142Cleared 510(K)
- K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.0182Cleared 510(K)
- K161427Pirouette 0352Cleared 510(K)
- K160256Polux , Minerva and Atropos PTA Balloon Dilatation Catheter2Cleared 510(K)
- K160004Crosstella OTW2Cleared 510(K)
- K160013Crosperio OTW2Cleared 510(K)
- K152934MMS PTA Balloon Catheter2Cleared 510(K)
- K152887Crosperio RX PTA Balloon Dilatation Catheter2Cleared 510(K)
- K152873Crosstella RX Balloon Dilatation Catheter2Cleared 510(K)
- K151141Cronus HP - High Pressure Peripheral Balloon Catheter2Cleared 510(K)
- K152665PolarCath Peripheral Dilatation System2Cleared 510(K)
- K152240Passeo-14 Peripheral Dilatation Catheter2Cleared 510(K)
- K151744Passeo-18 Peripheral Dilation Catheter2Cleared 510(K)
- K152080Metacross OTW PTA Balloon Dilatation Catheter2Cleared 510(K)
- K151678Chameleon PTA Balloon Catheter2Cleared 510(K)
- K152230Ebony PTA .014 RX Pheripheral Dilatation Catheter2Cleared 510(K)
- K151153Pirouette 0182Cleared 510(K)
- K150452ComboCath OTW PTA Dilatation Catheter2Cleared 510(K)
- K143193Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters2Cleared 510(K)
- K151317Armada 18 PTA Catheter2Cleared 510(K)
- K1430930.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)2Cleared 510(K)
- K150303XXL Vascular Balloon Dilatation Catheter2Cleared 510(K)
- K143041Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter2Cleared 510(K)
- K142954PTA 14 Balloon Dilatation Catheter OTW2Cleared 510(K)
- K143561ELM PTA Balloon Dilatation Catheter2Cleared 510(K)
- K150946FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm2Cleared 510(K)
- K143036Ebony PTA 0.035 Peripheral Dilatation Catheter2Cleared 510(K)
- K143652Vector PTA Balloon Dilatation Catheter2Cleared 510(K)
- K142459Ebony PTA 0.014 RX Peripheral Dilatation Catheter2Cleared 510(K)
- K142379Passeo-35 PTA Catheter2Cleared 510(K)
- K142654Fortrex 0.035 OTW PTA Balloon Catheter2Cleared 510(K)
- K141150PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K142261Ultraverse 035 PTA Balloon Dilatation Catheter2Cleared 510(K)
- K142300Arrow GPSCath Balloon Dialation Catheter (150 cm)2Cleared 510(K)
- K141521MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K141118NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K141112STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K140351ARROW GPSCATH BALLOON DILATATION CATHETER2Cleared 510(K)
- K133861FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX135CM, FLASH OSTIAL SYSTEM OTW-7.0MMX17MMX80CM2Cleared 510(K)
- K133843SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER2Cleared 510(K)
- K132810GLADIATOR ELITE PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K133043PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE2Cleared 510(K)
- K132020ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K132430STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K132777NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER2Cleared 510(K)
- K130397ARROW GPSCATH BALLOON DILATATION CATHETER2Cleared 510(K)
- K130414CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.0182Cleared 510(K)
- K131329VECTOR PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K130293ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K131199ULTRAVERSE RX PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K130911RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER2Cleared 510(K)
- K130786SLEEK OTW PTA CATHETER2Cleared 510(K)
- K130161PASSEO-352Cleared 510(K)
- K123544RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER2Cleared 510(K)
- K123358PACIFIC PLUS2Cleared 510(K)
- K122984ATLAS GOLD PTA DILATATION CATHETER2Cleared 510(K)
- K122379FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM2Cleared 510(K)
- K122070CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G2Cleared 510(K)
- K121856ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION2Cleared 510(K)
- K121175FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM2Cleared 510(K)
- K121442POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER2Cleared 510(K)
- K121385VECTOR2Cleared 510(K)
- K121402CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G2Cleared 510(K)
- K120164PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE2Cleared 510(K)
- K121265AMPHIRION PLUS PTA CATHETER2Cleared 510(K)
- K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER2Cleared 510(K)
- K120971ATLAS PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K120722RIVAL PTA DILATATION CATHETER2Cleared 510(K)
- K120805PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE2Cleared 510(K)
- K120738FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM2Cleared 510(K)
- K120677CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)2Cleared 510(K)
- K120660CONQUEST 40 PTA DILATATION CATHETER2Cleared 510(K)
- K113769GPSCATH BALLON DILATATION CATHETER2Cleared 510(K)
- K113681GLADIATOR PTA BALLOON DILATION CATHETER2Cleared 510(K)
- K113468ELM PTA BALLON DILATATION CATHETER2Cleared 510(K)
- K113300ATB ADVANCE PTA DILATATION CATHETER2Cleared 510(K)
- K112513EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K112697CHARGER PTA BALLON DILATATION CATHETER2Cleared 510(K)
- K111899ARMADA 35/35LL PTA CATHETER2Cleared 510(K)
- K111295.014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS2Cleared 510(K)
- K110319EVERCROSS 0.035 OTW PTA DILATATION CATHETER2Cleared 510(K)
- K103751MUSTANG BALLOON DILATATION CATHETERS2Cleared 510(K)
- K102482FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM2Cleared 510(K)
- K103354EBONY PTA .035 PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K103464PACIFIC XTREME PTCA BALLOON DILATATION CATHETER2Cleared 510(K)
- K102645WILLOW/ELM PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K102705ARMADA 14 PTA CATHETER2Cleared 510(K)
- K103322EVERCROSS 0.035 OTW PTA DILATION CATHETER2Cleared 510(K)
- K102035SLEEK OTW PTA CATHETERS2Cleared 510(K)
- K101361REEFLEX PTA CATHETER2Cleared 510(K)
- K101047PTA-DUO PTA BALLOON CATHETER2Cleared 510(K)
- K101062GLIDER PTA BALLOON CATHETER2Cleared 510(K)
- K100921ADMIRAL XTREME PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K090364EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE2Cleared 510(K)
- K093965ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS2Cleared 510(K)
- K100490LITEPAC, MODEL 6822Cleared 510(K)
- K093970PICA CATHETER2Cleared 510(K)
- K093139BANTAM,48XXXXXX, 50XXXXXX2Cleared 510(K)
- K093720STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO2Cleared 510(K)
- K093636STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX2Cleared 510(K)
- K093286POWERCROSS .018 OTW PTA DILATION CATHETER2Cleared 510(K)
- K092361REEF HP 0.035 OTW PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K092455MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM2Cleared 510(K)
- K092286FOX SV PTA CATHETER2Cleared 510(K)
- K080982STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS2Cleared 510(K)
- K081417FOXCROSS PTA CATHETER2Cleared 510(K)
- K080925FOX PLUS PTA CATHETER2Cleared 510(K)
- K080264MODIFICATION TO: FOX PLUS PTA CATHETER2Cleared 510(K)
- K072947SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS2Cleared 510(K)
- K072798VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER2Cleared 510(K)
- K073318BIPORE BALLOON DILATION CATHETER2Cleared 510(K)
- K073472VACCESS PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K072765PASSEO 182Cleared 510(K)
- K072824FOX SV PTA CATHETER2Cleared 510(K)
- K071309BLUE MAX BALLOON DILATATION CATHETER2Cleared 510(K)
- K071042POLARCATH PERIPHERAL DILATATION SYSTEM2Cleared 510(K)
- K071189CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K063563CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER2Cleared 510(K)
- K062843FOX SV PTA CATHETER2Cleared 510(K)
- K060960BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER2Cleared 510(K)
- K060959SYMMETRY BALLOON DILATATION CATHETER2Cleared 510(K)
- K052757PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER2Cleared 510(K)
- K052038PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM2Cleared 510(K)
- K051916POLAR CATH PERIPHERAL DILATATION SYSTEM2Cleared 510(K)
- K051042METRICATH GEMINI-P BALLOON CATHETER, MODELS RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, METRICATH CONSOLE, MODEL 10002Cleared 510(K)
- P950020FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)2PMA Approval
- K051519FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)2Cleared 510(K)
- K050645CORDIS AMIIA .014 PTA BALLOON CATHETER2Cleared 510(K)
- P950020ULTRA2 CUTTING BALLOON MONORAIL(MR)2PMA Approval
- P950020CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)2PMA Approval
- K041293BIOPORE BALLOON DILATION CATHETER2Cleared 510(K)
- K040954FOX PLUS PTA CATHETER2Cleared 510(K)
- K030742POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM2Cleared 510(K)
- K030062ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-02Cleared 510(K)
- K023504MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER2Cleared 510(K)
- K021996BOLTON PTA CATHETER2Cleared 510(K)
- K020854MODIFICATION TO FOX PTA CATHETER2Cleared 510(K)
- K003972NUMED GHOST II PTA CATHETERS2Cleared 510(K)
- K003276TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 1072Cleared 510(K)
- K003114NUMED TYSHAK AND Z-MED PTV CATHETERS2Cleared 510(K)
- K003052NUMED TYSHAK II AND Z-MED II PTV CATHETERS2Cleared 510(K)
- K003159CORDIS SLALOM PTA BALLOON CATHETER2Cleared 510(K)
- K991977TYSHAK, MODEL 102 AND Z-MED, MODEL 3022Cleared 510(K)
- K001134GAZELLE BALLOON DILATATION CATHETER2Cleared 510(K)
- K993913TRUE2Cleared 510(K)
- K001087PTA BALLOON CATHETER2Cleared 510(K)
- K000798TALON BALLOON DILATION CATHETER2Cleared 510(K)
- K992320MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER2Cleared 510(K)
- K000570BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA2Cleared 510(K)
- K993305TRANSLUMINAL BALLOON DILATATION CATHETER2Cleared 510(K)
- K000101RX VIATRAC 14 PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K993639RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K991540WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER2Cleared 510(K)
- K992825CORDIS EXTREME PTA BALLOON CATHETER2Cleared 510(K)
- K991811CORDIS MAXI DS PTA BALLOON CATHETER2Cleared 510(K)
- K983830COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER2Cleared 510(K)
- K983650BIPORE BALLOON DILATATION CATHETER2Cleared 510(K)
- K983055RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 10032Cleared 510(K)
- K980390PTA BALLOON CATHETER2Cleared 510(K)
- K981906MODIFICATION FOR PTA BALLOON CATHETER2Cleared 510(K)
- K973013OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER2Cleared 510(K)
- K981407OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER2Cleared 510(K)
- K972800PTA BALLOON CATHETER2Cleared 510(K)
- K973563BIPORE BALLOON DILATATION CATHETER2Cleared 510(K)
- K972512SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL2Cleared 510(K)
- K972744COURIER ST BALLOON DILATATION CATHETER2Cleared 510(K)
- K972357BLUE MAX - 20 BALLOON DILATATION CATHETER2Cleared 510(K)
- K971516CORDIS POWERFLEX PLUS PTA BALLOON CATHETER2Cleared 510(K)
- K971579CORDIS OPTA 5 PTA BALLOON CATHETER2Cleared 510(K)
- K971448CORDIS OPTA LP PTA BALLOON CATHETER2Cleared 510(K)
- K971577FOCUS-PV BALLOON DILATATION CATHETER2Cleared 510(K)
- K971010PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS2Cleared 510(K)
- K964881ULTRAVERSE PTA CATHETER2Cleared 510(K)
- K970466RADIUS PTCA GUIDEWIRE2Cleared 510(K)
- K953647MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING2Cleared 510(K)
- K970725OPTI-PLAST XL 5.5 F PTA CATHETER2Cleared 510(K)
- K970620CORDIS OPTA5 PTA BALLOON CATHETER2Cleared 510(K)
- K970379CHANNEL BALLOON CATHETER2Cleared 510(K)
- K970299JUPITER PTA CATHETERS (VARIOUS)2Cleared 510(K)
- K965183VANTAGE PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K963688FOCUS PV BALLOON DILATATION CATHETER2Cleared 510(K)
- K963000MAXI LD PTA BALLOON CATHETER2Cleared 510(K)
- K962945CORDIS OPTA PTA BALLOON CATHETER2Cleared 510(K)
- K961980BIPORE BALLOON DILATATION CATHETER2Cleared 510(K)
- K960517BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER2Cleared 510(K)
- K960501ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER2Cleared 510(K)
- K955886MEGA PTA BALLOON CATHETER2Cleared 510(K)
- K952884NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER2Cleared 510(K)
- K953298MS CLASSIQUE BALLOON DIATATION CATHETER2Cleared 510(K)
- K953608NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER2Cleared 510(K)
- K953569COURIER BALLOON DILATATION CATHETER2Cleared 510(K)
- K954313FOCUS PC BALLOON DILATATION CATHETER2Cleared 510(K)
- K952063XXL BALLON DILATATION CATHETER2Cleared 510(K)
- K953602SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER2Cleared 510(K)
- K945693CVD PERIFLOW(TM) (SMALL VESSEL) BALLOON DILATATION CATHETER2Cleared 510(K)
- K951248BRAUN PTA BALLOON CATHETER2Cleared 510(K)
- K952064FOCUS BALLOON DILATATION CATHETER2Cleared 510(K)
- K950119OPTA 5(TM) 5F PTA BALLOON CATHETER2Cleared 510(K)
- K944989NOPROFILE OLBERT CATHETER SYSTEM2Cleared 510(K)
- K946052POWERFLEX(TM) 5F PTA BALLOON CATHETER2Cleared 510(K)
- K945943CVD PERIFLOW(TM) BALLOON DILATATION CATHETER2Cleared 510(K)
- K945465CVD SMALL VESSEL BALLOON DILATATION CATHETER2Cleared 510(K)
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- K944815SCIMED VIPER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER2Cleared 510(K)
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- K942293MS CLASSIQUE BALLOON CATHETER2Cleared 510(K)
- K941706OPTI-PLAST ANGIOPLASTY CATHETER2Cleared 510(K)
- K943298MS CLASSIQUE BALLOON CATHETER2Cleared 510(K)
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- K934411MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE2Cleared 510(K)
- K934793SCIMED MAVERICK2Cleared 510(K)
- K933236CORDIS OPTA 5(TM), MODIFICATION2Cleared 510(K)
- K931009TYSHAK PERIPHERAL BALLOON DILATION CATHETER2Cleared 510(K)
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- K934191NEW BLUE MAX BALLOON DILATATION CATHETER2Cleared 510(K)
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- K924320ULTRA THIN BALLOON DILATATION CATHETER2Cleared 510(K)
- K923611ULTRA THIN BALLOON DILATATION CATHETER2Cleared 510(K)
- K933975MEADOX SURGIMED DISPOSABLE PRESSURE GUAGE FOR USE WITH THE OLBERT CATHETER SYSTEM2Cleared 510(K)
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- K926271SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO2Cleared 510(K)
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- K921577SCIMED SIDEWINDER TUOHY-BORST Y-ADAPTER2Cleared 510(K)
- K915347SCIMED VIPER CATHETER2Cleared 510(K)
- K921856TOTAL CROSS .021 PERCUT. TRANSLUMINAL ANGIO. CATH.2Cleared 510(K)
- K921943SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL2Cleared 510(K)
- K915895STEALTH DILATION CATHETER SYSTEM (MODIFIED)2Cleared 510(K)
- K920547ULTRA-THIN2Cleared 510(K)
- K915168PROFLEX 52Cleared 510(K)
- K915349PTA BALLOON CATHETER2Cleared 510(K)
- K914976OPTI-PLAST 5F PTA CATHETERS, MODIFICATION2Cleared 510(K)
- K914500OPTI-PLAST 5F PTA CATHETERS, MODIFICATION2Cleared 510(K)
- K913391TEGWIRE (TM)2Cleared 510(K)
- K913689SUB-4(TM), PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K913297SCHNEIDER MATCH-35(TM) PERCU TRANS ANGIOPLAS CATH2Cleared 510(K)
- K910965ECHOMARK CSI INTERFACE2Cleared 510(K)
- K910822BARD PERIPHERAL BALLOON DILATATION CATHETER2Cleared 510(K)
- K912317SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH2Cleared 510(K)
- K913112OPTI-PLAST 5F PTA CATHETERS2Cleared 510(K)
- K912984OPTI-PLAST 5F PTA CATHETERS, MODIFICATION2Cleared 510(K)
- K911870SCIMED OPTAMUM OPERATIVE PERIPHERAL ANGIOPLAS CATH2Cleared 510(K)
- K905698CORDIS OPTA 52Cleared 510(K)
- K911639OPTI-PLAST 5F PTA CATHETERS OVEN CURING PROCEDURE2Cleared 510(K)
- K911196SCHNEIDER TOTAL CROSS .021 PERCU TRANS ANGIO (PTA)2Cleared 510(K)
- K911215GESCO PER-Q-CATH NEEDLE2Cleared 510(K)
- K911130HEMOSTATIC Y CONNECTOR2Cleared 510(K)
- K911089STEALTH CATHETER SYSTEM2Cleared 510(K)
- K904984ADVANCE 418(TM)2Cleared 510(K)
- K911203TEGWIRE (TM)2Cleared 510(K)
- K910996OPTI-PLAST 5F PTA CATHETERS2Cleared 510(K)
- K910995MEDI-TECH BALLOON DILATATION CATHETER2Cleared 510(K)
- K904410MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM)2Cleared 510(K)
- K896520OWENS CATHETER2Cleared 510(K)
- K900677ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER2Cleared 510(K)
- K910155SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH2Cleared 510(K)
- K905773PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER2Cleared 510(K)
- K905250LOBOW2Cleared 510(K)
- K903417VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATH2Cleared 510(K)
- K902367OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER2Cleared 510(K)
- K902317PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH.2Cleared 510(K)
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- K897106MEDI-TECH DILATATION CATHETERS ULTRA THIN II2Cleared 510(K)
- K903606GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER2Cleared 510(K)
- K902091SCHNEIDER MONORAIL(TM) SOFTRAC-PTA(TM) CATHETER2Cleared 510(K)
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- K897124SMALL VESSEL BALLOON DILATATION CATHETER2Cleared 510(K)
- K901601HOLLOW MOTOR DRIVE UNIT2Cleared 510(K)
- K901767MODIFIED IVT PERIPHERAL ATHERECTOMY2Cleared 510(K)
- K901018MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS2Cleared 510(K)
- K894250LE PTA CATHETER2Cleared 510(K)
- K896403MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM2Cleared 510(K)
- K895179ACCESSOR PERIPHERAL DILATING GUIDE WIRE2Cleared 510(K)
- K894899EXPANSION OF THE CORDIS PTA DILATATION CATHETER2Cleared 510(K)
- K894944BALLOON DILATATION CATHETER2Cleared 510(K)
- K893411STEALTH DILATION CATHETER SYSTEM2Cleared 510(K)
- K890405USCI PTA BALLOON DILATATION CATHETER2Cleared 510(K)
- K890800ROTATING HEMOSTATIC VALVE2Cleared 510(K)
- K884327EXCEL Y-CONNECTOR CAT. #E-2012Cleared 510(K)
- K890325USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP2Cleared 510(K)
- K885247STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR2Cleared 510(K)
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- K884481CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE2Cleared 510(K)
- K882925ACS SCHWARTEN XT BALLOON DILATATION CATHETER2Cleared 510(K)
- K883346SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F2Cleared 510(K)
- K882052OMEGA NV(TM) BALLOON DILATATION CATHETER2Cleared 510(K)
- K880612CORDIS PTA DILATATION CATHETERS2Cleared 510(K)
- K875175MODIFIED PERIPHERAL DILATATION CATHETERS2Cleared 510(K)
- K881088ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)2Cleared 510(K)
- K881197SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K880298PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K880194KENSEY CATHETER2Cleared 510(K)
- K880158ANGIOPLASTY BALLOON INFLATION DEVICE2Cleared 510(K)
- K875064SCIMED INFLATION DEVICE, MODEL SM 20002Cleared 510(K)
- K874706MODIFIED SIMPSON PERIPHERAL ATHEROCATH2Cleared 510(K)
- K871796NUMED PTA CATHETERS2Cleared 510(K)
- K872542SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETER2Cleared 510(K)
- K870215DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)2Cleared 510(K)
- K871011SIMPSON PERIPHERAL ATHEROCATH(TM)2Cleared 510(K)
- K862550OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE2Cleared 510(K)
- K862467SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR2Cleared 510(K)
- K854319SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER2Cleared 510(K)
- K853746ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO2Cleared 510(K)
- K844913CORDIS PTA CATHETER-PERCUTANEOUS CATHETER2Cleared 510(K)
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- K851080GV MEDICAL, INC. LASTAC BALLOON DILATATION CATHETE2Cleared 510(K)
- K844972ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER2Cleared 510(K)
- K850760MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER2Cleared 510(K)
- K850075SCIMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILAT2Cleared 510(K)
- K843880LOW PROFILE STEERABLE BALLOON DILATION2Cleared 510(K)
- K843383MEDI-TECH DILATATION CATHETERS2Cleared 510(K)
- K841961MILLS OPERATIVE PERIPHERAL ANGIOPLASTY2Cleared 510(K)
- K843501BALLOON DILATION CATHETER2Cleared 510(K)
- K842556ADVANCED CARDIOVASCULAR BALLOON DILATA2Cleared 510(K)
- K834429PERIPHERAL DILATATION ANGIOPLASTY-CATH2Cleared 510(K)
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- K833248LOW PROFILE STEERABLE-INTRAOPERATIVE2Cleared 510(K)
- K832474FOGARTY-CHIN PERIPHERAL DILATION CATH2Cleared 510(K)
- K831659FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE2Cleared 510(K)
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- K812168CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH.2Cleared 510(K)
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- MAVSyringe, Balloon Inflation2Product Code
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2Product Code
- MLDMonitor, St Segment With Alarm2Product Code
- MTDCatheter, Intracardiac Mapping, High-Density Array2Product Code
- MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)2Product Code
- NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection2Product Code
- NKQGuidewire, Catheter, Reprocessed2Product Code
- NKRSystem, Catheter Control, Reprocessed2Product Code
- NKSCatheter, Steerable, Reprocessed2Product Code
- NKUInjector And Syringe, Angiographic, Balloon Inflation, Reprocessed2Product Code
- NKWActuator, Syringe, For Injector, Reprocessed2Product Code
- NLGCatheter, Intracardiac Mapping, High-Density, Reprocessed2Product Code
- NLHCatheter, Recording, Electrode, Reprocessed2Product Code
- NLICatheter, Angiography, Reprocessed2Product Code
- NMBCatheter, Oximeter, Fiber Optic, Reprocessed2Product Code
- NMKTrocar, Reprocessed2Product Code
- NMMCatheter, Angioplasty, Peripheral, Transluminal, Reprocessed2Product Code
- NPPReprocessed Blood Pressure Cuff2Product Code
- NTETemporary Carotid Catheter For Embolic Capture2Product Code
- NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon2Product Code
- OBICatheter, Pressure Monitoring, Cardiac2Product Code
- OBJCatheter, Ultrasound, Intravascular2Product Code
- OEDAntimicrobial Blood Pressure Cuff2Product Code
- OEQAngiography/Angioplasty Kit2Product Code
- OERAngioscopic Valvulotome Kit2Product Code
- OESCardiac Catheterization Kit2Product Code
- OEXCardiovascular Catheter Sheath Introducer Kit2Product Code
- OEZCardiovascular Procedure Kit2Product Code
- OFBCatheter Guide Wire Kit2Product Code
- OFCCatheter Introducer Kit2Product Code
- OFDCatheter Introducer Kit2Product Code
- OFECentral Venous Blood Pressure Kit2Product Code
- OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter2Product Code
- OFFCentral Venous Catheter Tray2Product Code
- OFHDigital Angiography Tray2Product Code
- ORDOptical Coherence Tomography, Intravascular Catheter2Product Code
- OFJLead Introducer Kit2Product Code
- OFKPercutaneous Atrial Catheter Kit2Product Code
- OFLPercutaneous Sheath Introducer Kit2Product Code
- OFNWinged Intravenous Catheterization Kit2Product Code
- OGZCatheter, Intravascular, Plaque Morphology Evaluation2Product Code
- OWQReprocessed Intravascular Ultrasound Catheter2Product Code
- OZTBalloon Aortic Valvuloplasty2Product Code
- PDUCatheter For Crossing Total Occlusions2Product Code
- PFANon-Invasive Central Venous Manometer2Product Code
- PJACoronary Vascular Physiologic Simulation Software2Product Code
- PNEReprocessed Catheter Introducer2Product Code
- PNOCatheter, Percutaneous, Cutting/Scoring2Product Code
- PPNPercutaneous Catheter, Ultrasound2Product Code
- PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access2Product Code
- PTLWire, Guide, Catheter, Exempt2Product Code
- PTMSyringe, Balloon Inflation, Exempt2Product Code
- PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures2Product Code
- QEKAngiographic Coronary Vascular Physiologic Simulation Software2Product Code
- QFJIntravascular Bleed Monitor2Product Code
- QJHReverse Central Venous Recanalization System2Product Code
- QMWCoronary Artery Disease Risk Indicator From Acoustic Heart Signals2Product Code
- QQIInterventional Cardiovascular Implant Simulation Software Device2Product Code
- QYFNeonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)2Product Code
- QYWHospital Cardiac Telemetry2Product Code
- QYXOutpatient Cardiac Telemetry2Product Code
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- Boston Scientific Corp.
- Trade Name
- FLEXATOME CUTTING BALLOON
- Generic Name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision Date
- 4/18/2000
- Days to Decision
- 1758 days
- Decision Code
- APPR
- FDA Decision
- Approval