510(k) Report

Devices descending from K053116

133 later devices reach Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-Xxxxxx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201328—
+5K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+5K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.20260—
+5K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.20260—
+5K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20240—
+5K241711Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.20241—
+5K241025JADE PLUS PTA Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+5K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…Goodman Co., Ltd.20241—
+5K213631Chocolate PTA Balloon CatheterMedtronic, Inc.20210—
+5K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+5K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20201—
+5K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC20180—
+5K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+5K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+5K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC20172—
+5K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501
+5K143652Vector PTA Balloon Dilatation CatheterVector Corporation, LLC20150—
+5K141597Mustang Balloon Dialation CatheterBoston Scientific Corporation20140—
+6K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.20250—
+6K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc.20250—
+6K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC20221—
+6K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+6K213728Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20211—
+6K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+6K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20200—
+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—
+7K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC20240—
+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—
+7K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20220—
+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—