510(k) Report

Devices descending from K032587

48 later devices reach Edwards Peripheral Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052149Edwards Peripheral Dilation CatheterEdwards Lifesciences, LLC200547—
+2K120722Rival Pta Dilatation CatheterBard Peripheral Vascular, Inc.20121—
+2K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc.2008442
+3K142261Ultraverse 035 PTA Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20140—
+3K121385VectorR4 Vascular, Inc.20122—
+3K120660Conquest 40 Pta Dilatation CatheterBard Peripheral Vascular, Inc.201231
+3K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.201036—
+4K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20250—
+4K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20241—
+4K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV…C.R. Bard, Inc.20222—
+4K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.20190—
+4K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc.20173—
+4K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+4K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc.201424—
+4K131329Vector Pta Balloon Dilatation CatheterR4 Vascular, Inc.20131—
+4K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201129—
+5K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+5K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20250—
+5K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+5K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard20171—
+5K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+5K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics20156—
+5K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc.201516—
+5K143652Vector PTA Balloon Dilatation CatheterVector Corporation, LLC20150—
+5K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201328—
+6K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+6K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.20260—
+6K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20240—
+6K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…Goodman Co., Ltd.20241—
+6K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+6K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20201—
+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—
+7K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.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—
+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—
+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—
+8K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20220—
+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—