510(k) Report

Devices descending from K103459

36 later devices reach Vascutrak Pta Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20250—
+1K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.20190—
+1K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc.20173—
+1K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+1K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc.201424—
+1K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201129—
+2K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+2K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+2K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard20171—
+2K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+2K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics20156—
+2K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc.201516—
+2K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201328—
+3K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+3K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.20260—
+3K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20240—
+3K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…Goodman Co., Ltd.20241—
+3K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+3K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20201—
+3K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+3K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+3K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC20172—
+4K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.20250—
+4K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC20221—
+4K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+4K213728Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20211—
+4K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+4K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20200—
+4K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+5K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…Shockwave Medical, Inc.20240—
+5K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC20240—
+5K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20240—
+5K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20241—
+5K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20220—
+5K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+6K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—