510(k) Report

Devices descending from K021735

165 later devices reach Boston Scientific Ultra-Soft SV Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter…Boston Scientific Corporation20161—
+1K053116Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp2005133—
+1K050389Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp2005164—
+2K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™…Boston Scientific Corporation20240—
+2K132430Sterling Over-the-Wire (Otw) Pta Balloon Dilatation CatheterBoston Scientific Corp201319—
+2K112513Ebony Pta 0.014 Peripheral Dilatation CatheterNatec Medical, Ltd.20113—
+2K093720Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon…Boston Scientific Corp200921—
+2K083139Vipersphere Pta Balloon CatheterCardiovascular Systems, Inc.20080—
+2K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc.2008351
+2K080982Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation CathetersBoston Scientific Corp200835—
+2K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20079615
+2K053118Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-XxxxxxBoston Scientific Corp200562—
+3K250219Dorado™ PTA Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20250—
+3K180007018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterCreagh Medical, Ltd.20181—
+3K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.201601
+3K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20161—
+3K152080Metacross OTW PTA Balloon Dilatation CatheterKANEKA Corporation20151—
+3K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501
+3K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation20154—
+3K143041Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire CatheterNatec Medical, Ltd.20150—
+3K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd.20151—
+3K141150Pta Balloon Dilatation CatheterBoston Scientific Corp20148—
+3K141112Sterling Over-the Wire Pta Balloon Dilatation CatheterBoston Scientific20144—
+3K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc.20138—
+3K121175Flash Pta Ballon Dilatation Catheter-5MM X 19MM X 135CMOstial Corporation20123—
+3K120722Rival Pta Dilatation CatheterBard Peripheral Vascular, Inc.20121—
+3K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20123—
+3K120660Conquest 40 Pta Dilatation CatheterBard Peripheral Vascular, Inc.201231
+3K110604VBB SystemSynthes201111
+3K111295.014 Monorail and Otw Pta Balloon Dilatation CathetersBoston Scientific Corporation201193
+3K110319Evercross 0.035 Otw Pta Dilatation CatheterEv3, Inc.20115—
+3K103751Mustang Balloon Dilatation CathetersBoston Scientific201115—
+3K102482Flash Pta Balloon Dilatation Catheter 5MM X 19MM X 135CM; Flash Pta Balloon Dilatation…Ostial Corporation20115—
+3K103534Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide WireTrireme Medical, Inc.20116—
+3K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.201036—
+3K101062Glider Pta Balloon CatheterTrireme Medical, Inc.20108—
+3K094019Glider Pta Balloon CatheterTrireme Medical, Inc.20104—
+3K093636Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters Model…Boston Scientific Corp200910—
+3K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc.2009142
+3K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc.2008442
+3K072798Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions200861
+3K063563Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation CatheterCordis Europa, N.V.200724—
+4K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20250—
+4K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…Brosmed Medical Co., Ltd.20250—
+4K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20241—
+4K242419018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterCreagh Medical Ltd. Dba Surmodics, Inc.20240—
+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—
+4K221057Viatrac 14 Plus Peripheral Dilatation CatheterAbbott Vascular20220—
+4K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV…C.R. Bard, Inc.20222—
+4K201170Athletis PTA Balloon Dilatation CatheterBoston Scientific Corporation20201—
+4K192399Infinity Angioplasty Balloon CatheterInfinity Angioplasty Balloon Company, LLC20203—
+4K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.20190—
+4K190753EverCrossTM 0.035 OTW PTA Dilatation CatheterMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)20190—
+4K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…Contego Medical, LLC20181—
+4K173894Jade PTA Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.20183—
+4K172033Pirouette High Pressure (HP)Arravasc, Ltd.20170—
+4K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc.20173—
+4K163479R2P Metacross RXKANEKA Corporation20170—
+4K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+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—
+4K150452ComboCath OTW PTA Dilatation CatheterSumma Therapeutics, LLC20151—
+4K142654Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC20140—
+4K142261Ultraverse 035 PTA Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20140—
+4K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+4K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc.201451
+4K133861Flash Ostial System Otw-7.0MMX17MMX135CM, Flash Ostial System Otw-7.0MMX17MMX80CMOstial Corporation20141—
+4K140351Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies,Inc Subsidiary of Teleflex ME20143—
+4K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc.201424—
+4K133043Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20132—
+4K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc.20137—
+4K130146Synthes Synflate Vertevral Balloon SystemSynthes (Usa), LLC20130—
+4K122379Flash Pta Balloon Dilatation Catheter - 4MM X 14MM X 135CM, Flash Pta Balloon Dilatation…Ostial Corporation201221
+4K122070Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20122—
+4K121385VectorR4 Vascular, Inc.20122—
+4K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc.20123—
+4K120738Flash Pta Balloon Dilatation Catheter-4.0X14MMX135CMOstial Corporation20124—
+4K120677Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014)Trireme Medical, Inc.20124—
+4K113681Gladiator Pta Balloon Dilation CatheterBoston Scientific20122—
+4K111738Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018)Trireme Medical, Inc.20115—
+4K112697Charger Pta Ballon Dilatation CatheterBoston Scientific20111—
+4K111899Armada 35/35LL Pta CatheterAbbott Vascular201101
+4K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201129—
+4K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc.20114—
+4K102705Armada 14 Pta CatheterAbbott Vascular, Inc.20104—
+4K071189Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V.200723—
+5K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.20260—
+5K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+5K260304WAVE PTA Balloon CatheterWAVE Medical AG20260—
+5K252512Armada™ 14 NC PTA CatheterAbbott Medical20260—
+5K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20250—
+5K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+5K240653SmartCardia 7L Platform (MCT)Smartcardia SA20241—
+5K230263Finesse™ Injectable PTA Balloon Dilatation CatheterSumma Therapeutics, LLC202301
+5K221414ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSilk Road Medical, Inc.20220—