510(k) Report

Devices descending from K935425

166 later devices reach Metronic Buchbinder Envoy Percutaneous Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022138Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp.2002108—
+1K991059Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support…Spectranetics Corp.1999165—
+2K082337Minnie Support CatheterVascular Solutions, Inc.200935—
+2K082561Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp.200818—
+2K072750Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066Spectranetics Corp.200766—
+2K033540Transxchange Support CatheterMedtronic Vascular20040—
+2K033678Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036…Spectranetics Corp.2004106—
+2K031417Ilt Safe Cross 0.035 Support Catheter, Model C135SN1Intra Luminal Therapeutics, Inc.20030—
+2K013284Lumend Frontrunner Cto Coronary CatheterLumend, Inc.200272—
+3K233637Cordis BRITECROSS Support CatheterCordis US Corp20240—
+3K211240ViperCross Support CathetersCardiovascular Systems, Inc.20211—
+3K193420XO Cross Support CatheterTransit Scientific20201—
+3K183305Crossing Support CatheterTractus Vascular, LLC20190—
+3K160848Wingman 18 Crossing CatheterReflow Medical, Inc.20163—
+3K141649Spex Support CatheterReflow Medical20146—
+3K133539Total AcrossMedtronic Vascular20142—
+3K130714Progigy Support CatheterRadius Medical, LLC20134—
+3K123311Qxmedical Access & Support CatheterQxmedical, LLC20134—
+3K121077NhancerImds Operations B.V.20120—
+3K112886Upstream Support CatheterUpstream Peripheral Technologies20120—
+3K112303Rubicon Support CatheterBoston Scientific20113—
+3K111556Glidecross Support CatheterTerumo Medical Corp.20110—
+3K110540Terumo Support CatheterTerumo Medical Corp.20116—
+3K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+3K101479Wingman Extendable Tip Support CatheterReflow Medical20105—
+3K091750Guideliner Catheter, Models 5571, 5572, 5573Vascular Solutions, Inc.200914—
+3K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp.200913—
+3K092299Trailblazer Support CatheterEv3, Inc.200921
+3K070212CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support…Ovalum, Ltd.20071—
+3K052258Vascular Solutions Skyway Support CatheterVascular Solutions, Inc.200580—
+3K023114Lumend Frontrunner Cto CatheterLumend, Inc.200369—
+4K253361Teleport Glide MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+4K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+4K231044R2P NavicrossTerumo Medical Corporation20231—
+4K220632Boss Crossing Support CatheterMarvao Medical Devices, Ltd.20220—
+4K214107XO CROSS CORONARY Support CatheterTransit Scientific, LLC20220—
+4K210322XO Cross Support CatheterTransit Scientific, LLC20210—
+4K212725ViperCross Support CathetersCardiovascular Systems, Inc.20210—
+4K200317Support CatheterQxmedical, LLC20200—
+4K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+4K183000ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc.20181—
+4K180889Tractus Crossing Support CatheterTractus Vascular, LLC20180—
+4K173799NaviCross 0.018Terumo Corporation20182—
+4K173662speX Support CatheterReflow Medical, Inc.20175—
+4K170914TXM Support CatheterTexasmedical Technologies, Inc.20170—
+4K170041XableCath Support CatheterXablecath, Inc.20171—
+4K171897Approach CTO Microwire GuideCook Incorporated201703
+4K171913Rubicon 14, 18 and 35 Support CathetersBoston Scientific Corporation20171—
+4K170996Wingman 14C Crossing CatheterReflow Medical, Inc.20172—
+4K160561Boosting CatheterQxmedical, LLC20160—
+4K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.)20160—
+4K152401Stingray LP CatheterBoston Scientific Corporation20151—
+4K140910Centercross CatheterRoxwood Medical, Inc.20143—
+4K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+4K122795Stingray GuidewiresBridgepoint Medical201201
+4K122394Rubicon 18 Support CatheterBoston Scientific Corp20122—
+4K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+4K112100M2 Navigation Catheter and Guideliner Navigation CatheterVascular Solutions, Inc.20120—
+4K120178Wingman Extendable Tip Support CatheterReflow Medical20124—
+4K112082Guideliner V2 CatheterVascular Solutions, Inc.2011121
+4K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610Vascular Solutions, Inc.200744—
+4K040067Clirpath Excimer Laser CatheterSpectranetics Corp.200436—
+4K031005Lumend Frontrunner GW Cto CatheterLumend, Inc.200332—
+5K223633Rubicon™ Control Support Catheter (H749394323506A1)Boston Scientific Corporation20230—
+5K231176Stingray LP CatheterBoston Scientific20230—
+5K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+5K211251ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc.20210—
+5K200094speX LP Support CatheterReflow Medical20201—
+5K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+5K193012speX Support CatheterReflow Medical20202—
+5K190393Wingman 14C Crossing CatheterReflow Medical, Inc.20191—
+5K183357XableCath Crossing CatheterXablecath, Inc.20190—
+5K180986XableCath Support Catheter Product FamilyXablecath, Inc.20180—
+5K172090GuideLiner V3 CatheterVascular Solutions, Inc.20178—
+5K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc201725
+5K161901TrapLiner catheterVascular Solutions, Inc.20171—
+5K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+5K132420Wingman Extendable Tip Support CatheterReflow Medical20133—
+5K121745Mantaray GuidewiresBridgepoint Medical20120—
+5K120707Switch-IT CatheterVascular Solutions, Inc.20120—
+5K101117Lev-or Dilation Catheter OtwBaylis Medical Co., Inc.20100—
+5K091345Gopher Gold Catheter, Model 5620Vascular Solutions, Inc.200920—
+5K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc.200921—
+5K051670RF Tunneler WireBaylis Medical Co., Inc.20066—
+5K052296Clirpath Turbo Excimer Laser CathetersSpectranetics Corp.200524—
+5K0434652.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp.200525—
+5K033535Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc.200431—
+6K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+6K252315Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc.20250—
+6K233350SINC Support CatheterReflow Medical, Inc.20240—
+6K220691LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter ExtensionSeigla Medical, Inc.20221—
+6K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)Ra Medical Systems,Inc20211—
+6K210188coraCrossReflow Medical20210—
+6K210110GuidionImds Operations B.V.20211—
+6K201811coraForce and coraFlex Support CathetersReflow Medical, Inc.20201—
+6K183353Telescope Guide Extension CatheterMedtronic, Inc.20193—
+6K180088TrapLiner catheterVascular Solutions, Inc.20180—
+6K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+6K151880Wingman Crossing CatheterReflow Medical20150—
+6K142065Turnpike CatheterVascular Solutions, Inc.20144—