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
+1K132430Sterling Over-the-Wire (Otw) Pta Balloon Dilatation CatheterBoston Scientific Corp201319—
+1K093720Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon…Boston Scientific Corp200921—
+1K083139Vipersphere Pta Balloon CatheterCardiovascular Systems, Inc.20080—
+1K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc.2008351
+1K080982Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation CathetersBoston Scientific Corp200835—
+1K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20079615
+2K250219Dorado™ PTA Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20250—
+2K180007018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterCreagh Medical, Ltd.20181—
+2K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.201601
+2K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter…Boston Scientific Corporation20161—
+2K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20161—
+2K152080Metacross OTW PTA Balloon Dilatation CatheterKANEKA Corporation20151—
+2K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation20154—
+2K141150Pta Balloon Dilatation CatheterBoston Scientific Corp20148—
+2K141112Sterling Over-the Wire Pta Balloon Dilatation CatheterBoston Scientific20144—
+2K120722Rival Pta Dilatation CatheterBard Peripheral Vascular, Inc.20121—
+2K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20123—
+2K120660Conquest 40 Pta Dilatation CatheterBard Peripheral Vascular, Inc.201231
+2K110604VBB SystemSynthes201111
+2K111295.014 Monorail and Otw Pta Balloon Dilatation CathetersBoston Scientific Corporation201193
+2K110319Evercross 0.035 Otw Pta Dilatation CatheterEv3, Inc.20115—
+2K103751Mustang Balloon Dilatation CathetersBoston Scientific201115—
+2K103534Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide WireTrireme Medical, Inc.20116—
+2K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.201036—
+2K101062Glider Pta Balloon CatheterTrireme Medical, Inc.20108—
+2K094019Glider Pta Balloon CatheterTrireme Medical, Inc.20104—
+2K093636Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters Model…Boston Scientific Corp200910—
+2K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc.2009142
+2K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc.2008442
+3K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20250—
+3K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…Brosmed Medical Co., Ltd.20250—
+3K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20241—
+3K242419018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterCreagh Medical Ltd. Dba Surmodics, Inc.20240—
+3K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™…Boston Scientific Corporation20240—
+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—
+3K192399Infinity Angioplasty Balloon CatheterInfinity Angioplasty Balloon Company, LLC20203—
+3K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.20190—
+3K190753EverCrossTM 0.035 OTW PTA Dilatation CatheterMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)20190—
+3K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…Contego Medical, LLC20181—
+3K173894Jade PTA Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.20183—
+3K172033Pirouette High Pressure (HP)Arravasc, Ltd.20170—
+3K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc.20173—
+3K163479R2P Metacross RXKANEKA Corporation20170—
+3K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+3K160004Crosstella OTWKANEKA Corporation20162—
+3K160013Crosperio OTWKANEKA Corporation20160—
+3K152873Crosstella RX Balloon Dilatation CatheterKANEKA Corporation20161—
+3K152887Crosperio RX PTA Balloon Dilatation CatheterKANEKA Corporation20160—
+3K151141Cronus HP - High Pressure Peripheral Balloon CatheterNipro Medical Corporation20161—
+3K150452ComboCath OTW PTA Dilatation CatheterSumma Therapeutics, LLC20151—
+3K142654Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC20140—
+3K142261Ultraverse 035 PTA Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20140—
+3K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+3K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc.201451
+3K140351Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies,Inc Subsidiary of Teleflex ME20143—
+3K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc.201424—
+3K133043Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20132—
+3K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc.20137—
+3K130146Synthes Synflate Vertevral Balloon SystemSynthes (Usa), LLC20130—
+3K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc.20138—
+3K122070Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20122—
+3K121385VectorR4 Vascular, Inc.20122—
+3K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc.20123—
+3K120677Chocolate Pta Ballon Catheter (Over the Wire) Guide Wire (0.014)Trireme Medical, Inc.20124—
+3K113681Gladiator Pta Balloon Dilation CatheterBoston Scientific20122—
+3K111738Chocolate Pta Balloon Catheter (Over the Wire) Guide Wire (0.014 and 0.018)Trireme Medical, Inc.20115—
+3K112697Charger Pta Ballon Dilatation CatheterBoston Scientific20111—
+3K111899Armada 35/35LL Pta CatheterAbbott Vascular201101
+3K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201129—
+3K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc.20114—
+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—
+4K240653SmartCardia 7L Platform (MCT)Smartcardia SA20241—
+4K230263Finesse™ Injectable PTA Balloon Dilatation CatheterSumma Therapeutics, LLC202301
+4K214038Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.20222—
+4K220410Ebony HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20220—
+4K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc.20220—
+4K202231JADEOrbusNeich Medical (Shenzhen) Co., Ltd.20201—
+4K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation20200—
+4K201794JadeOrbusNeich Medical (Shenzhen) Co., Ltd.20201—
+4K191275All’InCath 035M PTA Balloon Dilatation CatheterNexstep Medical20200—
+4K190037Cronus HP PTA Balloon CatheterNipro Medical Corporation20190—
+4K172494PROTEUS PTA Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20171—
+4K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard20171—
+4K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+4K1430930.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)Hotspur Technologies, Inc.,20150—
+4K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics20156—
+4K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc.201516—
+4K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd.20151—
+4K142300Arrow GPSCath Balloon Dialation Catheter (150 cm)Hotspur Technologies, Inc.,20141—
+4K132810Gladiator Elite Pta Balloon Dilatation CatheterBoston Scientific Corp20141—
+4K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc.20136—
+4K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—
+4K131329Vector Pta Balloon Dilatation CatheterR4 Vascular, Inc.20131—