510(k) Report

Devices descending from K051916

98 later devices reach Polar Cath Peripheral Dilatation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060572Modification to Polarcath Peripheral Dilatation SystemBoston Scientific Corporation200697—
+2K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20079615
+3K250219Dorado™ PTA Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20250—
+3K120722Rival Pta Dilatation CatheterBard Peripheral Vascular, Inc.20121—
+3K120660Conquest 40 Pta Dilatation CatheterBard Peripheral Vascular, Inc.201231
+3K103751Mustang Balloon Dilatation CathetersBoston Scientific201115—
+3K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.201036—
+3K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc.2008442
+3K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc.2008351
+4K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20250—
+4K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20241—
+4K231402HP PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20230—
+4K214009D·Kaptain PTA High Pressure Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20230—
+4K212215Tiche PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20220—
+4K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV…C.R. Bard, Inc.20222—
+4K201170Athletis PTA Balloon Dilatation CatheterBoston Scientific Corporation20201—
+4K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.20190—
+4K172033Pirouette High Pressure (HP)Arravasc, Ltd.20170—
+4K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc.20173—
+4K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.201601
+4K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+4K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20161—
+4K152080Metacross OTW PTA Balloon Dilatation CatheterKANEKA Corporation20151—
+4K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation20154—
+4K142654Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC20140—
+4K142261Ultraverse 035 PTA Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20140—
+4K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc.201424—
+4K121385VectorR4 Vascular, Inc.20122—
+4K113681Gladiator Pta Balloon Dilation CatheterBoston Scientific20122—
+4K112697Charger Pta Ballon Dilatation CatheterBoston Scientific20111—
+4K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201129—
+4K110319Evercross 0.035 Otw Pta Dilatation CatheterEv3, Inc.20115—
+4K103534Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide WireTrireme Medical, Inc.20116—
+4K101062Glider Pta Balloon CatheterTrireme Medical, Inc.20108—
+4K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc.2009142
+5K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.20260—
+5K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+5K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20250—
+5K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+5K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…Brosmed Medical Co., Ltd.20250—
+5K220410Ebony HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20220—
+5K190753EverCrossTM 0.035 OTW PTA Dilatation CatheterMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)20190—
+5K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard20171—
+5K163479R2P Metacross RXKANEKA Corporation20170—
+5K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+5K160004Crosstella OTWKANEKA Corporation20162—
+5K160013Crosperio OTWKANEKA Corporation20160—
+5K152873Crosstella RX Balloon Dilatation CatheterKANEKA Corporation20161—
+5K152887Crosperio RX PTA Balloon Dilatation CatheterKANEKA Corporation20160—
+5K151141Cronus HP - High Pressure Peripheral Balloon CatheterNipro Medical Corporation20161—
+5K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics20156—
+5K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc.201516—
+5K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc.201451
+5K132810Gladiator Elite Pta Balloon Dilatation CatheterBoston Scientific Corp20141—
+5K131329Vector Pta Balloon Dilatation CatheterR4 Vascular, Inc.20131—
+5K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc.20137—
+5K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc.20138—
+5K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201328—
+5K122070Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20122—
+5K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc.20123—
+5K120677Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014)Trireme Medical, Inc.20124—
+5K111738Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018)Trireme Medical, Inc.20115—
+5K111899Armada 35/35LL Pta CatheterAbbott Vascular201101
+5K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc.20114—
+6K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+6K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.20260—
+6K240653SmartCardia 7L Platform (MCT)Smartcardia SA20241—
+6K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20240—
+6K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…Goodman Co., Ltd.20241—
+6K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation20200—
+6K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+6K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20201—
+6K190037Cronus HP PTA Balloon CatheterNipro Medical Corporation20190—
+6K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+6K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+6K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC20172—
+6K143652Vector PTA Balloon Dilatation CatheterVector Corporation, LLC20150—
+6K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd.20151—
+6K141597Mustang Balloon Dialation CatheterBoston Scientific Corporation20140—
+6K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc.20136—
+6K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—
+7K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.20260—
+7K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.20250—
+7K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC20221—
+7K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+7K213631Chocolate PTA Balloon CatheterMedtronic, Inc.20210—
+7K213728Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20211—
+7K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+7K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20200—
+7K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+7K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501
+8K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…Shockwave Medical, Inc.20240—
+8K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC20240—
+8K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20240—
+8K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20241—
+8K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20220—
+8K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+9K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—