510(k) Report

Devices descending from K971010

93 later devices reach Peripheral Transluminal Angioplasty Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201246PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)Qualimed USA, LLC20210—
+1K133843Saber Percutaneous Transluminal Angioplasty Dilatation CatheterCordis Corporation201461
+1K100303Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2076-Xxyy, 2092-Xxyy, 2105-XxyyAngioscore, Inc.201032—
+1K083139Vipersphere Pta Balloon CatheterCardiovascular Systems, Inc.20080—
+1K080151Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039Angioscore, Inc.2008365
+1K072225Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.2007375
+1K063657Vascutrak Pta Dilation CatheterYmed, Inc.200652—
+1K050629Angiosculpt Scoring Balloon CatheterAngioscore, Inc.200538—
+1K021898Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.2002241
+2K221245PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.20220—
+2K151153Pirouette 018Arravasc Limited20154—
+2K113103Splitwire Percutaneous Transluminal Angioplasty Scoring DeviceRex Medical20125—
+2K112182Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201129—
+2K110767Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201130—
+2K101735Angiosculpt Pta Scoring Balloon Catheter Model 2039-Xxyy, 2155-XxyyAngioscore, Inc.201029—
+2K091966Angiosculpt Pta Scoring Balloon Catheter, Models 2076-6040, 2092-6040, 2105-6040Angioscore, Inc.200933—
+2K082059Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.200834—
+2K081220Modification to Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.200834—
+2K073025Vascutrak II Pta Dilatation CatheterThermopeutix, Inc. Dba Ymed, Inc.200748—
+2K033393Absolute .035 Self-Expanding Biliary Stent SystemGuidant Corp.200335
+2K032137Precise RX Nitinol Stent Transhepatic Biliary SystemCordis Corp.200301
+2K032457Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.20039—
+2K031777Modeification to: Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.2003103
+2K024303Edwards Lifesciences Lifestent NT18 Self-Expanding Biliary Stent and Delivery SystemEdwards Lifesciences, LLC20034—
+2K031197Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.20030—
+2K030409Smart Nitinol Stent Endoscopic Biliary SystemCordis Corp.20030—
+2K023217Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.200221
+3K193495XO Score Percutaneous Transluminal Angioplasty Scoring CatheterTransit Scientific20202—
+3K173621Advocate PTA CatheterMerit Medical Systems, Inc.20171—
+3K162316Pirouette 014Arravasc, Ltd.20162—
+3K161427Pirouette 035Arravasc Limited20162—
+3K152789Flex Scoring CatheterVenturemed Group20161—
+3K150634AngioSculpt PTA Scoring Baloon CathetersSpectranetrics20156—
+3K142983AngioSculpt PTA Scoring Balloon Catheter with HydroCross CoatingAngioscore, Inc.201516—
+3K133998Angiosculpt Pta Scoring Balloon with Hydrocross CaotingAngioscore, Inc.201424—
+3K122685Angiosculpt Pta Scoring Balloon CatheterAngioscore, Inc.201328—
+3K082343Vascutrak 2, Models: V14 and V18Ymed, Inc.200847—
+3K072708Absolute Pro .035 Self-Expanding Stent SystemAbbott Vascular-Vascular Solutions20080—
+3K072720Alimaxx-B Uncovered Biliary Stent SystemAlveolus, Inc.200816
+3K062798Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB…Cordis Corp.200842
+3K060557Suresave TM Self-Expandable Nitinol Stent and Precision TM Delivery Catheter-SS06120060Idev Technologies, Inc.20066—
+3K053404Lifestent Flexstart Biliary Stent SystemEdwards Lifesciences, LLC20052103
+3K042985Lifestent NT35 Biliary Stent SystemEdwards Lifesciences, LLC20043—
+3K042969Modification to Smart Control Nitinol Stent Transhepatic Biliary SystemCordis Corp.200402
+4K241478Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd.20240—
+4K232013Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040…Goodman Co., Ltd.20241—
+4K221986XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterTransit Scientific, LLC20221—
+4K202187FLEX Vessel Prep SystemVenturemed Group, Inc.20200—
+4K193181Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20201—
+4K192907Advocate PTA CatheterMerit Medical Systems, Inc.20190—
+4K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC20172—
+4K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+4K130792Lifestent Biliary Stent System, Lifestent XL Biliary Stent SystemC.R. Bard, Inc.20130—
+4K111627Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc.20120—
+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—
+4K111766Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary SystemsIdev Technologies, Inc.201121
+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—
+4K093893Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc.201041
+4K093947Alimaxx-B Uncovered Biliary Stent System EndoscopicMerit Medical Systems, Inc.20100—
+4K071646Supera Interwoven Self-Expanding Biliary Nitinol Stent Delivery Catheter, Model #…Idev Technologies, Inc.20085—
+4K060487Lifestent Flexstar XL Biliary Stent SystemEdwards Lifesciences, LLC20061—
+5K243944Aperta NSE PTA Balloon Dilatation CatheterGoodman Co., Ltd.20250—
+5K242254D·Kutting™ LL Peripheral Scoring Balloon Dilatation CatheterDk Medical Technology Co., Ltd.20250—
+5K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+5K232258XO Constrain™ Percutaneous Transluminal Angioplasty Constraining CatheterTransit Scientific, LLC20240—
+5K213728Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20211—
+5K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20200—
+5K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc.20190—
+5K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc.20173—
+5K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+5K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—
+5K122546Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc.20121—
+6K261778JADE SCORE PTA Scoring Balloon Dilatation CatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+6K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+6K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20220—
+6K213631Chocolate PTA Balloon CatheterMedtronic, Inc.20210—
+6K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+6K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+6K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard20171—
+6K130591Supera VeritasIdev Technologies, Inc.20130—
+7K260012UltraScore™ Focused Force PTA BalloonBard Peripheral Vascular, Inc.20260—
+7K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+7K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+7K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+8K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…Shockwave Medical, Inc.20240—
+8K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20240—
+8K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20241—
+8K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+9K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—