510(k) Report

Devices descending from K001134

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc.20137—
+5K130146Synthes Synflate Vertevral Balloon SystemSynthes (Usa), LLC20130—
+5K122379Flash Pta Balloon Dilatation Catheter - 4MM X 14MM X 135CM, Flash Pta Balloon Dilatation…Ostial Corporation201221
+5K121385VectorR4 Vascular, Inc.20122—
+5K120738Flash Pta Balloon Dilatation Catheter-4.0X14MMX135CMOstial Corporation20124—
+5K113681Gladiator Pta Balloon Dilation CatheterBoston Scientific20122—
+5K112697Charger Pta Ballon Dilatation CatheterBoston Scientific20111—
+5K111899Armada 35/35LL Pta CatheterAbbott Vascular201101
+5K102705Armada 14 Pta CatheterAbbott Vascular, Inc.20104—
+5K071189Cordis Aviator Plus Pta Balloon Dilatation CatheterCordis Europa, N.V.200723—
+6K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd.20260—
+6K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+6K260304WAVE PTA Balloon CatheterWAVE Medical AG20260—
+6K252512Armada™ 14 NC PTA CatheterAbbott Medical20260—
+6K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20250—
+6K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+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—
+6K230263Finesse™ Injectable PTA Balloon Dilatation CatheterSumma Therapeutics, LLC202301
+6K221414ENROUTE Enflate Transcarotid RX Balloon Dilatation CatheterSilk Road Medical, Inc.20220—
+6K214038Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.20222—
+6K220410Ebony HP PTA OTW 0.035 CatheterNatec Medical, Ltd.20220—
+6K221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionContego Medical, Inc.20220—
+6K213631Chocolate PTA Balloon CatheterMedtronic, Inc.20210—
+6K213728Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20211—
+6K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20200—
+6K202231JADEOrbusNeich Medical (Shenzhen) Co., Ltd.20201—
+6K201377SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation20200—
+6K201794JadeOrbusNeich Medical (Shenzhen) Co., Ltd.20201—
+6K191275All’InCath 035M PTA Balloon Dilatation CatheterNexstep Medical20200—
+6K190037Cronus HP PTA Balloon CatheterNipro Medical Corporation20190—
+6K172494PROTEUS PTA Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20171—
+6K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard20171—
+6K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+6K151317Armada 18 PTA CatheterAbbott Vascular20150—
+6K1430930.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm)Hotspur Technologies, Inc.,20150—
+6K150946FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x…Ostial Corporation20150—
+6K142300Arrow GPSCath Balloon Dialation Catheter (150 cm)Hotspur Technologies, Inc.,20141—
+6K132810Gladiator Elite Pta Balloon Dilatation CatheterBoston Scientific Corp20141—
+6K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc.20136—
+6K131329Vector Pta Balloon Dilatation CatheterR4 Vascular, Inc.20131—
+6K121352Armada 14XXT Pta CatheterAbbott Vascular20120—
+6K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp.201210—
+7K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+7K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.20260—
+7K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.20260—
+7K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.20250—
+7K241711Oscar Peripheral Multifunctional Catheter systemBiotronik, Inc.20241—
+7K241025JADE PLUS PTA Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20240—
+7K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20220—
+7K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC20180—
+7K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+7K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+7K143652Vector PTA Balloon Dilatation CatheterVector Corporation, LLC20150—
+7K141597Mustang Balloon Dialation CatheterBoston Scientific Corporation20140—
+7K121442Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corporation201292
+8K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc.20250—
+8K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+8K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+8K201333SABER .035 PTA Dilatation CatheterCordis Corporation20201—
+8K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+8K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation201461
+9K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…Shockwave Medical, Inc.20240—
+9K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20240—
+9K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20241—
+9K221245PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+9K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+9K210626SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation CatheterCordis Corporation20210—
+9K151153Pirouette 018Arravasc Limited20154—
+10K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—
+10K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+10K162316Pirouette 014Arravasc, Ltd.20162—
+10K161427Pirouette 035Arravasc Limited20162—
+11K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—