510(k) Report

Devices descending from K991059

165 later devices reach Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082337Minnie Support CatheterVascular Solutions, Inc.200935—
+1K082561Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp.200818—
+1K072750Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066Spectranetics Corp.200766—
+1K033540Transxchange Support CatheterMedtronic Vascular20040—
+1K033678Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036…Spectranetics Corp.2004106—
+1K022138Spectranetics 0.035 Support Catheter, Model 518-028Spectranetics Corp.2002108—
+1K013284Lumend Frontrunner Cto Coronary CatheterLumend, Inc.200272—
+2K233637Cordis BRITECROSS Support CatheterCordis US Corp20240—
+2K211240ViperCross Support CathetersCardiovascular Systems, Inc.20211—
+2K193420XO Cross Support CatheterTransit Scientific20201—
+2K183305Crossing Support CatheterTractus Vascular, LLC20190—
+2K160848Wingman 18 Crossing CatheterReflow Medical, Inc.20163—
+2K141649Spex Support CatheterReflow Medical20146—
+2K133539Total AcrossMedtronic Vascular20142—
+2K130714Progigy Support CatheterRadius Medical, LLC20134—
+2K123311Qxmedical Access & Support CatheterQxmedical, LLC20134—
+2K121077NhancerImds Operations B.V.20120—
+2K112886Upstream Support CatheterUpstream Peripheral Technologies20120—
+2K112303Rubicon Support CatheterBoston Scientific20113—
+2K111556Glidecross Support CatheterTerumo Medical Corp.20110—
+2K110540Terumo Support CatheterTerumo Medical Corp.20116—
+2K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+2K101479Wingman Extendable Tip Support CatheterReflow Medical20105—
+2K091750Guideliner Catheter, Models 5571, 5572, 5573Vascular Solutions, Inc.200914—
+2K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp.200913—
+2K092299Trailblazer Support CatheterEv3, Inc.200921
+2K070212CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support…Ovalum, Ltd.20071—
+2K052258Vascular Solutions Skyway Support CatheterVascular Solutions, Inc.200580—
+2K031417Ilt Safe Cross 0.035 Support Catheter, Model C135SN1Intra Luminal Therapeutics, Inc.20030—
+2K023114Lumend Frontrunner Cto CatheterLumend, Inc.200369—
+3K253361Teleport Glide MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+3K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+3K231044R2P NavicrossTerumo Medical Corporation20231—
+3K220632Boss Crossing Support CatheterMarvao Medical Devices, Ltd.20220—
+3K214107XO CROSS CORONARY Support CatheterTransit Scientific, LLC20220—
+3K210322XO Cross Support CatheterTransit Scientific, LLC20210—
+3K212725ViperCross Support CathetersCardiovascular Systems, Inc.20210—
+3K200317Support CatheterQxmedical, LLC20200—
+3K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+3K183000ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc.20181—
+3K180889Tractus Crossing Support CatheterTractus Vascular, LLC20180—
+3K173799NaviCross 0.018Terumo Corporation20182—
+3K173662speX Support CatheterReflow Medical, Inc.20175—
+3K170914TXM Support CatheterTexasmedical Technologies, Inc.20170—
+3K170041XableCath Support CatheterXablecath, Inc.20171—
+3K171897Approach CTO Microwire GuideCook Incorporated201703
+3K171913Rubicon 14, 18 and 35 Support CathetersBoston Scientific Corporation20171—
+3K170996Wingman 14C Crossing CatheterReflow Medical, Inc.20172—
+3K160561Boosting CatheterQxmedical, LLC20160—
+3K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.)20160—
+3K152401Stingray LP CatheterBoston Scientific Corporation20151—
+3K140910Centercross CatheterRoxwood Medical, Inc.20143—
+3K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+3K122795Stingray GuidewiresBridgepoint Medical201201
+3K122394Rubicon 18 Support CatheterBoston Scientific Corp20122—
+3K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+3K112100M2 Navigation Catheter and Guideliner Navigation CatheterVascular Solutions, Inc.20120—
+3K120178Wingman Extendable Tip Support CatheterReflow Medical20124—
+3K112082Guideliner V2 CatheterVascular Solutions, Inc.2011121
+3K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610Vascular Solutions, Inc.200744—
+3K040067Clirpath Excimer Laser CatheterSpectranetics Corp.200436—
+3K031005Lumend Frontrunner GW Cto CatheterLumend, Inc.200332—
+4K223633Rubicon™ Control Support Catheter (H749394323506A1)Boston Scientific Corporation20230—
+4K231176Stingray LP CatheterBoston Scientific20230—
+4K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+4K211251ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc.20210—
+4K200094speX LP Support CatheterReflow Medical20201—
+4K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+4K193012speX Support CatheterReflow Medical20202—
+4K190393Wingman 14C Crossing CatheterReflow Medical, Inc.20191—
+4K183357XableCath Crossing CatheterXablecath, Inc.20190—
+4K180986XableCath Support Catheter Product FamilyXablecath, Inc.20180—
+4K172090GuideLiner V3 CatheterVascular Solutions, Inc.20178—
+4K170349RA-308 Excimer Laser System, Excimer Laser CatheterRa Medical Systems,Inc201725
+4K161901TrapLiner catheterVascular Solutions, Inc.20171—
+4K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+4K132420Wingman Extendable Tip Support CatheterReflow Medical20133—
+4K121745Mantaray GuidewiresBridgepoint Medical20120—
+4K120707Switch-IT CatheterVascular Solutions, Inc.20120—
+4K101117Lev-or Dilation Catheter OtwBaylis Medical Co., Inc.20100—
+4K091345Gopher Gold Catheter, Model 5620Vascular Solutions, Inc.200920—
+4K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc.200921—
+4K051670RF Tunneler WireBaylis Medical Co., Inc.20066—
+4K052296Clirpath Turbo Excimer Laser CathetersSpectranetics Corp.200524—
+4K0434652.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011Spectranetics Corp.200525—
+4K033535Lumend Frontrunner Cto Catheter and AccessoriesLumend, Inc.200431—
+5K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+5K252315Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc.20250—
+5K233350SINC Support CatheterReflow Medical, Inc.20240—
+5K220691LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter ExtensionSeigla Medical, Inc.20221—
+5K210664DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)Ra Medical Systems,Inc20211—
+5K210188coraCrossReflow Medical20210—
+5K210110GuidionImds Operations B.V.20211—
+5K201811coraForce and coraFlex Support CathetersReflow Medical, Inc.20201—
+5K183353Telescope Guide Extension CatheterMedtronic, Inc.20193—
+5K180088TrapLiner catheterVascular Solutions, Inc.20180—
+5K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+5K151880Wingman Crossing CatheterReflow Medical20150—
+5K142065Turnpike CatheterVascular Solutions, Inc.20144—
+5K141547Wingman Extendable Tip Support CatheterReflow Medical20142Class I