510(k) Report

Devices descending from K100303

32 later devices reach Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201129—
+1K110767Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201130—
+1K101735Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2155-XxyyAngioscore, Inc.201029—
+2K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc.201516—
+2K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc.201424—
+2K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201328—
+3K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20201—
+3K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC20172—
+3K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+3K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics20156—
+4K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+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—
+4K213728Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20211—
+4K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20200—
+4K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+4K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+5K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+5K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.20250—
+5K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC20221—
+5K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20220—
+5K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+5K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+6K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC20240—
+6K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+6K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+6K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+7K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…Shockwave Medical, Inc.20240—
+7K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20240—
+7K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20241—
+7K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+8K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—