510(k) Report

Devices descending from K133998

24 later devices reach Angiosculpt Pta Scoring Balloon with Hydrocross Caoting through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics20156—
+1K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc.201516—
+2K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20240—
+2K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…Goodman Co., Ltd.20241—
+2K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+2K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20201—
+2K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+3K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.20250—
+3K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+3K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC20221—
+3K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20200—
+3K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+4K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+4K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC20240—
+4K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+4K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+5K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+5K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+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—
+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—
+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—