510(k) Report

Devices descending from K001134

175 later devices reach Gazelle Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063657Vascutrak Pta Dilation CatheterYmed, Inc.200652—
+1K021735Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Scimed, Inc.200216523
+2K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter…Boston Scientific Corporation20161—
+2K113103Splitwire Percutaneous Transluminal Angioplasty Scoring DeviceRex Medical20125—
+2K100303Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-XxyyAngioscore, Inc.201032—
+2K073025Vascutrak II Pta Dilatation CatheterThermopeutix, Inc. Dba Ymed, Inc.200748—
+2K053116Sterling Otw Pta Balloon Dilatation Catheter, Model H74939032-XxxxxxBoston Scientific Corp2005133—
+2K050389Ultra-Soft SV Balloon Dilatation CatheterBoston Scientific Corp2005164—
+3K241683Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling™…Boston Scientific Corporation20240—
+3K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+3K152789Flex Scoring CatheterVenturemed Group20161—
+3K132430Sterling Over-the-Wire (Otw) Pta Balloon Dilatation CatheterBoston Scientific Corp201319—
+3K112513Ebony Pta 0.014 Peripheral Dilatation CatheterNatec Medical, Ltd.20113—
+3K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201129—
+3K110767Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201130—
+3K101735Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2155-XxyyAngioscore, Inc.201029—
+3K093720Sterling SL Monorail Pta Balloon Dilatation Catheters Sterling SL Over-the-Wire Balloon…Boston Scientific Corp200921—
+3K083139Vipersphere Pta Balloon CatheterCardiovascular Systems, Inc.20080—
+3K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc.2008351
+3K082343Vascutrak 2, Models: V14 and V18Ymed, Inc.200847—
+3K080982Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation CathetersBoston Scientific Corp200835—
+3K072283Dorado Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20079615
+3K053118Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-XxxxxxBoston Scientific Corp200562—
+4K250219Dorado™ PTA Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20250—
+4K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC20221—
+4K202187FLEX Vessel Prep SystemVenturemed Group, Inc.20200—
+4K180007018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterCreagh Medical, Ltd.20181—
+4K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.201601
+4K160256Polux , Minerva and Atropos PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20161—
+4K152080Metacross OTW PTA Balloon Dilatation CatheterKANEKA Corporation20151—
+4K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501
+4K150865Metacross RX PTA Balloon Dilitation CatheterKANEKA Corporation20154—
+4K143041Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire CatheterNatec Medical, Ltd.20150—
+4K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc.201516—
+4K142459Ebony PTA 0.014 RX Peripheral Dilatation CatheterNatec Medical, Ltd.20151—
+4K141150Pta Balloon Dilatation CatheterBoston Scientific Corp20148—
+4K141112Sterling Over-the Wire Pta Balloon Dilatation CatheterBoston Scientific20144—
+4K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc.201424—
+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—
+4K121175Flash Pta Ballon Dilatation Catheter-5MM X 19MM X 135CMOstial Corporation20123—
+4K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc.20123—
+4K120722Rival Pta Dilatation CatheterBard Peripheral Vascular, Inc.20121—
+4K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20123—
+4K120660Conquest 40 Pta Dilatation CatheterBard Peripheral Vascular, Inc.201231
+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—
+4K110604VBB SystemSynthes201111
+4K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc.20114—
+4K111295.014 Monorail and Otw Pta Balloon Dilatation CathetersBoston Scientific Corporation201193
+4K110319Evercross 0.035 Otw Pta Dilatation CatheterEv3, Inc.20115—
+4K103751Mustang Balloon Dilatation CathetersBoston Scientific201115—
+4K102482Flash Pta Balloon Dilatation Catheter 5MM X 19MM X 135CM; Flash Pta Balloon Dilatation…Ostial Corporation20115—
+4K103534Gliderxtreme Pta Balloon Catheter (CB) (Over the Wire) 0.014 / 0.018 Guide WireTrireme Medical, Inc.20116—
+4K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.201036—
+4K101062Glider Pta Balloon CatheterTrireme Medical, Inc.20108—
+4K094019Glider Pta Balloon CatheterTrireme Medical, Inc.20104—
+4K093636Sterling ES Monorail and Over-the-Wire Pta Balloon Dilatation Catheters Model…Boston Scientific Corp200910—
+4K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc.2009142
+4K083657Conquest Pta Balloon Dilatation CatheterC.R. Bard, Inc.2008442
+4K072798Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions200861
+4K063563Cordis Amila Percutaneous Transluminal Angioplasty (Pta) Balloon Dilatation CatheterCordis Europa, N.V.200724—
+5K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20250—
+5K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon…Brosmed Medical Co., Ltd.20250—
+5K241040Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20241—
+5K242419018 Hydrophilic Coated OTW PTA Balloon Dilatation CatheterCreagh Medical Ltd. Dba Surmodics, Inc.20240—
+5K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC20240—
+5K231402HP PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20230—
+5K214009D·Kaptain PTA High Pressure Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20230—
+5K212215Tiche PTA Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20220—
+5K221057Viatrac 14 Plus Peripheral Dilatation CatheterAbbott Vascular20220—
+5K212588Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV…C.R. Bard, Inc.20222—
+5K201170Athletis PTA Balloon Dilatation CatheterBoston Scientific Corporation20201—
+5K192399Infinity Angioplasty Balloon CatheterInfinity Angioplasty Balloon Company, LLC20203—
+5K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20201—
+5K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.20190—
+5K190753EverCrossTM 0.035 OTW PTA Dilatation CatheterMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)20190—
+5K181128Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin…Contego Medical, LLC20181—
+5K173894Jade PTA Balloon Dilatation CatheterOrbusneich Medical Trading, Inc.20183—
+5K172033Pirouette High Pressure (HP)Arravasc, Ltd.20170—
+5K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc.20173—
+5K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC20172—
+5K163479R2P Metacross RXKANEKA Corporation20170—
+5K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+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—
+5K150452ComboCath OTW PTA Dilatation CatheterSumma Therapeutics, LLC20151—
+5K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics20156—
+5K142654Fortrex 0.035 OTW PTA Balloon CatheterCovidien, LLC20140—
+5K142261Ultraverse 035 PTA Balloon Dilatation CatheterBard Peripheral Vascular, Inc.20140—
+5K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+5K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc.201451
+5K133861Flash Ostial System Otw-7.0MMX17MMX135CM, Flash Ostial System Otw-7.0MMX17MMX80CMOstial Corporation20141—
+5K140351Arrow Gpscath Balloon Dilatation CatheterHotspur Technologies,Inc Subsidiary of Teleflex ME20143—
+5K133043Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20132—
+5K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—