510(k) Report

Devices descending from K042624

99 later devices reach Amphirion Deep 0.014 Otw Pta Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142954PTA 14 Balloon Dilatation Catheter OTWTexasmedical Technologies, Inc.20150—
+1K102645Willow/Elm Pta Balloon Dilatation CatheterCreagh Medical, Ltd.20106—
+1K083919Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L.2009261
+1K063657Vascutrak Pta Dilation CatheterYmed, Inc.200652—
+1K050276Diver C.E. CatheterInvatec Innovative Technologies, S.R.L.2005171
+2K230191Arise™ UHP Dilatation CatheterCreagh Medical, Ltd.20230—
+2K171251014 Hydrophilic Coated PTA Balloon Dilatation CatheterCreagh Medical20172—
+2K143561ELM PTA Balloon Dilatation CatheterO'Connell Regulatory Consultants, Inc.20150—
+2K123358Pacific PlusMedtronic Vascular20131—
+2K113103Splitwire Percutaneous Transluminal Angioplasty Scoring DeviceRex Medical20125—
+2K113468Elm Pta Ballon Dilatation CatheterCreagh Medical, Ltd.20110—
+2K112513Ebony Pta 0.014 Peripheral Dilatation CatheterNatec Medical, Ltd.20113—
+2K103464Pacific Xtreme Ptca Balloon Dilatation CatheterMedtronic, Inc.201091
+2K102705Armada 14 Pta CatheterAbbott Vascular, Inc.20104—
+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—
+2K071727QXT Extraction CatheterVascular Solutions, Inc.200712—
+2K060092Quickcat Extraction CatheterKensey Nash Corp.200621
+2K051917Diver C.E. CatheterInvatec Innovative Technologies, S.R.L.2005131
+3K260304WAVE PTA Balloon CatheterWAVE Medical AG20260—
+3K252512Armada™ 14 NC PTA CatheterAbbott Medical20260—
+3K202800Pacific Plus PTA CatheterMedtronic Vascular,Inc (Formerly D.B.A Ev3 Inc.,Covidien, LLC)20200—
+3K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+3K200700Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty)…Creagh Medical, Ltd.20201—
+3K152789Flex Scoring CatheterVenturemed Group20161—
+3K152230Ebony PTA .014 RX Pheripheral Dilatation CatheterNatec Medical201501
+3K151317Armada 18 PTA CatheterAbbott Vascular20150—
+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—
+3K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation201461
+3K121352Armada 14XXT Pta CatheterAbbott Vascular20120—
+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—
+3K082343Vascutrak 2, Models: V14 and V18Ymed, Inc.200847—
+3K073519Quickcat Extraction Catheter, Model 60090-01Kensey Nash Corp.200811
+3K072810Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc.200711—
+4K221245PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+4K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC20221—
+4K211044Sublime Radial Access 018 RX Dilatation CatheterCreagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,20210—
+4K202187FLEX Vessel Prep SystemVenturemed Group, Inc.20200—
+4K151153Pirouette 018Arravasc Limited20154—
+4K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc.201516—
+4K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc.201424—
+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—
+4K121402Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire Chocolate Pta Balloon…Trireme Medical, Inc.20123—
+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—
+4K112281Gliderxtreme Pta Ballon Catheter (Over the Wire) 0.018 Guide Wire 6100-Xxxxx, 6100CB-XXXXTrireme Medical, Inc.20114—
+4K103459Vascutrak Pta Dilatation CatheterC.R. Bard, Inc.201036—
+4K091703HD Guide Catheter, Model 90019, 90022, 90023, 90120, 90121, 90130, 90131Concentric Medical, Inc.20090—
+4K083784Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010…Vascular Solutions, Inc.200910—
+5K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20250—
+5K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC20240—
+5K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20201—
+5K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.20190—
+5K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+5K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc.20173—
+5K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC20172—
+5K162467Twin-Pass TorqueVascular Solutions, Inc.20172—
+5K162316Pirouette 014Arravasc, Ltd.20162—
+5K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+5K161427Pirouette 035Arravasc Limited20162—
+5K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics20156—
+5K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—
+5K112382Terumo Aspriation CatheterTerumo Medical Corporation20110—
+5K103405Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4…Vascular Solutions, Inc.201041
+5K090977Piggyback Wire ConverterVascular Solutions, Inc.20090—
+6K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+6K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+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—
+6K213631Chocolate PTA Balloon CatheterMedtronic, Inc.20210—
+6K213728Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20211—
+6K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20200—
+6K200324NHancer RxImds Operations B.V.20201—
+6K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—
+6K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard20171—
+6K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+6K161506Penumbra Aspiration SystemPenumbra, Inc.20163—
+7K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+7K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.20260—
+7K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.20250—
+7K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20220—
+7K210431ReCrossImds Operations B.V.20210—
+7K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+7K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+7K163618INDIGO Aspiration SystemPenumbra, Inc.20172—
+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—
+8K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+8K180412Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and CanisterPenumbra, Inc.20181—
+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—
+9K220683INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)Penumbra, Inc.20220—
+9K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+10K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—