510(k) Report

Devices descending from K000101

79 later devices reach RX Viatrac 14 Peripheral Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063657Vascutrak Pta Dilation CatheterYmed, Inc.200652—
+1K021996Bolton Pta CatheterBolton Medical, Inc.20020—
+1K020854Modification to Fox Pta CatheterJomed AG200216—
+1K012050Viatrac 14 Plus Peripheral Dilatation CatheterGuidant Corp.20017—
+2K113103Splitwire Percutaneous Transluminal Angioplasty Scoring DeviceRex Medical20125—
+2K100303Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-XxyyAngioscore, Inc.201032—
+2K072798Viatrac 14 Plus Peripheral Dilation CatheterAbbott Vascular-Vascular Solutions200861
+2K073025Vascutrak II Pta Dilatation CatheterThermopeutix, Inc. Dba Ymed, Inc.200748—
+2K060927Ceres Pta Catheter Models PTA018,PTA035 Various SizesCeres Medical Systems, LLC20060—
+2K040954Fox Plus Pta CatheterAbbott Laboratories, Inc.20045—
+2K033217Pheron Pta CatheterBiotronik, Inc.20038—
+3K221057Viatrac 14 Plus Peripheral Dilatation CatheterAbbott Vascular20220—
+3K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+3K152789Flex Scoring CatheterVenturemed Group20161—
+3K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201129—
+3K110767Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201130—
+3K102705Armada 14 Pta CatheterAbbott Vascular, Inc.20104—
+3K101735Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2155-XxyyAngioscore, Inc.201029—
+3K082933Passeo-35 Pta CatheterBiotronik, Inc.20085—
+3K082343Vascutrak 2, Models: V14 and V18Ymed, Inc.200847—
+3K080264Modification to: Fox Plus Pta CatheterAbbott Vascular-Vascular Solutions20081—
+3K072765Passeo 18Biotronik, Inc.20077—
+3K051519Fox SV Pta Catheter (82XXX Series). Fox Plus Pta Catheter (12XXX Series)Abbott Laboratories (Perclose, Inc.)20052—
+4K260304WAVE PTA Balloon CatheterWAVE Medical AG20260—
+4K252512Armada™ 14 NC PTA CatheterAbbott Medical20260—
+4K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC20221—
+4K202187FLEX Vessel Prep SystemVenturemed Group, Inc.20200—
+4K151744Passeo-18 Peripheral Dilation CatheterBiotronik, Inc.20151—
+4K151317Armada 18 PTA CatheterAbbott Vascular20150—
+4K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc.201516—
+4K142379Passeo-35 PTA CatheterBiotronik, Inc.20143—
+4K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc.201424—
+4K130161Passeo-35Biotronik, Inc.20130—
+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—
+4K121352Armada 14XXT Pta CatheterAbbott Vascular20120—
+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—
+4K080925Fox Plus Pta CatheterAbbott Vascular, Inc.20080—
+4K062843Fox SV Pta CatheterAbbott Laboratories20061—
+5K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20250—
+5K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…Biotronik, Inc.20250—
+5K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC20240—
+5K222065Passeo-35 Xeo Peripheral Dilatation CatheterBiotronik, Inc.20231—
+5K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20201—
+5K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.20190—
+5K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc.20173—
+5K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC20172—
+5K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+5K152240Passeo-14 Peripheral Dilatation CatheterBiotronik, Inc.20151—
+5K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics20156—
+5K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—
+5K072824Fox SV Pta CatheterAbbott Laboratories20070—
+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—
+6K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard20171—
+6K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+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—
+7K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+7K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+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—
+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—
+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—