510(k) Report

Devices descending from K082343

47 later devices reach Vascutrak 2, Models: V14 and V18 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122070Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20122—
+1K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc.20123—
+1K120677Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014)Trireme Medical, Inc.20124—
+1K111738Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018)Trireme Medical, Inc.20115—
+1K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc.20114—
+1K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.201036—
+1K100303Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-XxyyAngioscore, Inc.201032—
+2K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20250—
+2K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.20190—
+2K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc.20173—
+2K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+2K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc.201424—
+2K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—
+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—
+3K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+3K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+3K213631Chocolate PTA Balloon CatheterMedtronic, Inc.20210—
+3K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard20171—
+3K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+3K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics20156—
+3K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc.201516—
+3K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201328—
+4K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+4K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.20260—
+4K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20240—
+4K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…Goodman Co., Ltd.20241—
+4K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+4K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20201—
+4K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+4K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+4K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC20172—
+5K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.20250—
+5K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC20221—
+5K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+5K213728Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20211—
+5K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+5K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20200—
+5K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+6K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…Shockwave Medical, Inc.20240—
+6K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC20240—
+6K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20240—
+6K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20241—
+6K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20220—
+6K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+7K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—