510(k) Report

Devices descending from K021735

165 later devices reach Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K214038Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.20222—
+5K220410Ebony HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20220—
+5K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc.20220—
+5K202231JADEOrbusNeich Medical (Shenzhen) Co., Ltd.20201—
+5K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation20200—
+5K201794JadeOrbusNeich Medical (Shenzhen) Co., Ltd.20201—
+5K191275All’InCath 035M PTA Balloon Dilatation CatheterNexstep Medical20200—
+5K190037Cronus HP PTA Balloon CatheterNipro Medical Corporation20190—
+5K172494PROTEUS PTA Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20171—
+5K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard20171—
+5K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+5K151317Armada 18 PTA CatheterAbbott Vascular20150—
+5K1430930.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)Hotspur Technologies, Inc.,20150—
+5K150946FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x…Ostial Corporation20150—
+5K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics20156—
+5K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc.201516—
+5K142300Arrow GPSCath Balloon Dialation Catheter (150 cm)Hotspur Technologies, Inc.,20141—
+5K132810Gladiator Elite Pta Balloon Dilatation CatheterBoston Scientific Corp20141—
+5K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc.20136—
+5K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—
+5K131329Vector Pta Balloon Dilatation CatheterR4 Vascular, Inc.20131—
+5K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201328—
+5K121352Armada 14XXT Pta CatheterAbbott Vascular20120—
+5K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp.201210—
+6K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+6K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.20260—
+6K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.20260—
+6K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20240—
+6K241711Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.20241—
+6K241025JADE PLUS PTA Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+6K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…Goodman Co., Ltd.20241—
+6K213631Chocolate PTA Balloon CatheterMedtronic, Inc.20210—
+6K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+6K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20201—
+6K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC20180—
+6K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+6K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+6K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC20172—
+6K143652Vector PTA Balloon Dilatation CatheterVector Corporation, LLC20150—
+6K141597Mustang Balloon Dialation CatheterBoston Scientific Corporation20140—
+6K121442Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation201292
+7K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.20250—
+7K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc.20250—
+7K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC20221—
+7K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+7K213728Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20211—
+7K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+7K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20200—
+7K201333SABER .035 PTA Dilatation CatheterCordis Corporation20201—
+7K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+7K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation201461
+8K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…Shockwave Medical, Inc.20240—
+8K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC20240—
+8K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20240—
+8K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20241—
+8K221245PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+8K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20220—
+8K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+8K210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterCordis Corporation20210—
+8K151153Pirouette 018Arravasc Limited20154—
+9K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—
+9K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+9K162316Pirouette 014Arravasc, Ltd.20162—
+9K161427Pirouette 035Arravasc Limited20162—
+10K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—