510(k) Report

Devices descending from K063657

52 later devices reach Vascutrak Pta Dilation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113103Splitwire Percutaneous Transluminal Angioplasty Scoring DeviceRex Medical20125—
+1K100303Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-XxyyAngioscore, Inc.201032—
+1K073025Vascutrak II Pta Dilatation CatheterThermopeutix, Inc. Dba Ymed, Inc.200748—
+2K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+2K152789Flex Scoring CatheterVenturemed Group20161—
+2K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201129—
+2K110767Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201130—
+2K101735Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2155-XxyyAngioscore, Inc.201029—
+2K082343Vascutrak 2, Models: V14 and V18Ymed, Inc.200847—
+3K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC20221—
+3K202187FLEX Vessel Prep SystemVenturemed Group, Inc.20200—
+3K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc.201516—
+3K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc.201424—
+3K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201328—
+3K122070Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20122—
+3K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc.20123—
+3K120677Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014)Trireme Medical, Inc.20124—
+3K111738Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018)Trireme Medical, Inc.20115—
+3K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc.20114—
+3K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.201036—
+4K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20250—
+4K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC20240—
+4K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20201—
+4K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.20190—
+4K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc.20173—
+4K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC20172—
+4K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+4K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics20156—
+4K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—
+5K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+5K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+5K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20240—
+5K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…Goodman Co., Ltd.20241—
+5K213631Chocolate PTA Balloon CatheterMedtronic, Inc.20210—
+5K213728Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20211—
+5K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20200—
+5K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard20171—
+5K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+6K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+6K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.20260—
+6K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.20250—
+6K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20220—
+6K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+6K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+7K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+7K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+7K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+8K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…Shockwave Medical, Inc.20240—
+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—
+8K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+9K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—