510(k) Report

Devices descending from K014212

123 later devices reach Bard Conquest Pta Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K131002Vida PTV Dilataton CatheterC.R. Bard, Inc.20134—
+5K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—
+6K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20260—
+6K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.20260—
+6K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.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—
+6K213631Chocolate PTA Balloon CatheterMedtronic, Inc.20210—
+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—
+6K163231Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd.201712
+6K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501
+6K141985True BA V Balloon Valvuloplasty CatheterC.R. Bard, Inc.20143—
+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—
+7K170635Chameleon PTA Balloon CatheterAv Medical Technologies, Ltd.20170—
+8K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—