510(k) Report

Devices descending from K012913

107 later devices reach Bard Utaverse Small Vessel Pta Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093965Ultraverse 014 and 018 Balloon Dilatation CathetersC.R. Bard, Inc.201015—
+1K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20079615
+2K250219Dorado™ PTA Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20250—
+2K121856Ultraverse 014 and 018 Pta Balloon Dilatation Catheters Line ExtensionC.R. Bard, Inc.201214—
+2K120722Rival Pta Dilatation CatheterBard Peripheral Vascular, Inc.20121—
+2K120660Conquest 40 Pta Dilatation CatheterBard Peripheral Vascular, Inc.201231
+2K103751Mustang Balloon Dilatation CathetersBoston Scientific201115—
+2K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.201036—
+2K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc.2008442
+2K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc.2008351
+3K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20250—
+3K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20241—
+3K231402HP PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20230—
+3K214009D·Kaptain PTA High Pressure Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20230—
+3K212215Tiche PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20220—
+3K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV…C.R. Bard, Inc.20222—
+3K201170Athletis PTA Balloon Dilatation CatheterBoston Scientific Corporation20201—
+3K192318Ultraverse 014 and 018 PTA Balloon Dilatation CathetersBard Peripheral Vascular, Inc.20191—
+3K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.20190—
+3K172033Pirouette High Pressure (HP)Arravasc, Ltd.20170—
+3K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc.20173—
+3K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.201601
+3K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+3K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20161—
+3K152080Metacross OTW PTA Balloon Dilatation CatheterKANEKA Corporation20151—
+3K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation20154—
+3K142654Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC20140—
+3K142261Ultraverse 035 PTA Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20140—
+3K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc.201424—
+3K131199Ultraverse RX Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.201311—
+3K121385VectorR4 Vascular, Inc.20122—
+3K113681Gladiator Pta Balloon Dilation CatheterBoston Scientific20122—
+3K112697Charger Pta Ballon Dilatation CatheterBoston Scientific20111—
+3K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201129—
+3K110319Evercross 0.035 Otw Pta Dilatation CatheterEv3, Inc.20115—
+3K103534Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide WireTrireme Medical, Inc.20116—
+3K101062Glider Pta Balloon CatheterTrireme Medical, Inc.20108—
+3K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc.2009142
+4K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.20260—
+4K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+4K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20250—
+4K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+4K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…Brosmed Medical Co., Ltd.20250—
+4K223177Highlander™ 014 PTA Balloon Dilatation CatheterC.R. Bard, Inc.20230—
+4K220410Ebony HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20220—
+4K190753EverCrossTM 0.035 OTW PTA Dilatation CatheterMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)20190—
+4K180921Sapphire II PRO Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.20183—
+4K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard20171—
+4K171290Vela RX PTA Balloon Dilatation CatheterCuratia Medical20170—
+4K163479R2P Metacross RXKANEKA Corporation20170—
+4K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+4K160004Crosstella OTWKANEKA Corporation20162—
+4K160013Crosperio OTWKANEKA Corporation20160—
+4K152873Crosstella RX Balloon Dilatation CatheterKANEKA Corporation20161—
+4K152887Crosperio RX PTA Balloon Dilatation CatheterKANEKA Corporation20160—
+4K151141Cronus HP - High Pressure Peripheral Balloon CatheterNipro Medical Corporation20161—
+4K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics20156—
+4K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc.201516—
+4K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc.201451
+4K132810Gladiator Elite Pta Balloon Dilatation CatheterBoston Scientific Corp20141—
+4K131329Vector Pta Balloon Dilatation CatheterR4 Vascular, Inc.20131—
+4K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc.20137—
+4K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc.20138—
+4K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201328—
+4K122070Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20122—
+4K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc.20123—
+4K120677Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014)Trireme Medical, Inc.20124—
+4K111738Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018)Trireme Medical, Inc.20115—
+4K111899Armada 35/35LL Pta CatheterAbbott Vascular201101
+4K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc.20114—
+5K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+5K252295RyureiTerumo Corporation20260—
+5K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.20260—
+5K240653SmartCardia 7L Platform (MCT)Smartcardia SA20241—
+5K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20240—
+5K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…Goodman Co., Ltd.20241—
+5K211349Selebrek PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+5K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation20200—
+5K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+5K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20201—
+5K200269Sapphire II PROOrbusneich Medical Trading, Inc.20200—
+5K190037Cronus HP PTA Balloon CatheterNipro Medical Corporation20190—
+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—
+5K143652Vector PTA Balloon Dilatation CatheterVector Corporation, LLC20150—
+5K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd.20151—
+5K141597Mustang Balloon Dialation CatheterBoston Scientific Corporation20140—
+5K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc.20136—
+5K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—
+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—
+6K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501