510(k) Report

Devices descending from K033678

106 later devices reach Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123311Qxmedical Access & Support CatheterQxmedical, LLC20134—
+1K121077NhancerImds Operations B.V.20120—
+1K112303Rubicon Support CatheterBoston Scientific20113—
+1K111556Glidecross Support CatheterTerumo Medical Corp.20110—
+1K110540Terumo Support CatheterTerumo Medical Corp.20116—
+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—
+1K052258Vascular Solutions Skyway Support CatheterVascular Solutions, Inc.200580—
+2K253361Teleport Glide MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20260—
+2K233637Cordis BRITECROSS Support CatheterCordis US Corp20240—
+2K231044R2P NavicrossTerumo Medical Corporation20231—
+2K220632Boss Crossing Support CatheterMarvao Medical Devices, Ltd.20220—
+2K211240ViperCross Support CathetersCardiovascular Systems, Inc.20211—
+2K200317Support CatheterQxmedical, LLC20200—
+2K193420XO Cross Support CatheterTransit Scientific20201—
+2K183305Crossing Support CatheterTractus Vascular, LLC20190—
+2K183000ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc.20181—
+2K173799NaviCross 0.018Terumo Corporation20182—
+2K170041XableCath Support CatheterXablecath, Inc.20171—
+2K171913Rubicon 14, 18 and 35 Support CathetersBoston Scientific Corporation20171—
+2K160561Boosting CatheterQxmedical, LLC20160—
+2K160848Wingman 18 Crossing CatheterReflow Medical, Inc.20163—
+2K141649Spex Support CatheterReflow Medical20146—
+2K133539Total AcrossMedtronic Vascular20142—
+2K130714Progigy Support CatheterRadius Medical, LLC20134—
+2K122394Rubicon 18 Support CatheterBoston Scientific Corp20122—
+2K112886Upstream Support CatheterUpstream Peripheral Technologies20120—
+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
+2K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610Vascular Solutions, Inc.200744—
+3K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+3K223633Rubicon™ Control Support Catheter (H749394323506A1)Boston Scientific Corporation20230—
+3K214107XO CROSS CORONARY Support CatheterTransit Scientific, LLC20220—
+3K210322XO Cross Support CatheterTransit Scientific, LLC20210—
+3K212725ViperCross Support CathetersCardiovascular Systems, Inc.20210—
+3K211251ViperCath XC Peripheral Exchange CatheterCardiovascular Systems, Inc.20210—
+3K180889Tractus Crossing Support CatheterTractus Vascular, LLC20180—
+3K180986XableCath Support Catheter Product FamilyXablecath, Inc.20180—
+3K173662speX Support CatheterReflow Medical, Inc.20175—
+3K170914TXM Support CatheterTexasmedical Technologies, Inc.20170—
+3K170996Wingman 14C Crossing CatheterReflow Medical, Inc.20172—
+3K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.)20160—
+3K140910Centercross CatheterRoxwood Medical, Inc.20143—
+3K112100M2 Navigation Catheter and Guideliner Navigation CatheterVascular Solutions, Inc.20120—
+3K120178Wingman Extendable Tip Support CatheterReflow Medical20124—
+3K112082Guideliner V2 CatheterVascular Solutions, Inc.2011121
+3K101117Lev-or Dilation Catheter OtwBaylis Medical Co., Inc.20100—
+3K091345Gopher Gold Catheter, Model 5620Vascular Solutions, Inc.200920—
+3K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc.200921—
+4K200094speX LP Support CatheterReflow Medical20201—
+4K193012speX Support CatheterReflow Medical20202—
+4K190393Wingman 14C Crossing CatheterReflow Medical, Inc.20191—
+4K172090GuideLiner V3 CatheterVascular Solutions, Inc.20178—
+4K161901TrapLiner catheterVascular Solutions, Inc.20171—
+4K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+4K142065Turnpike CatheterVascular Solutions, Inc.20144—
+4K132420Wingman Extendable Tip Support CatheterReflow Medical20133—
+4K120707Switch-IT CatheterVascular Solutions, Inc.20120—
+4K101659Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM) Model 5300, 5301Vascular Solutions, Inc.201041
+4K101647Wildcat 5F Guidewire Support Catheter, Mode W500Avinger, Inc.20102—
+4K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc.201018—
+5K233350SINC Support CatheterReflow Medical, Inc.20240—
+5K220691LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter ExtensionSeigla Medical, Inc.20221—
+5K214106QuikPass CatheterTraverse Vascular, Inc.20220—
+5K210188coraCrossReflow Medical20210—
+5K210647SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterVascular Solutions, LLC20210—
+5K210110GuidionImds Operations B.V.20211—
+5K201811coraForce and coraFlex Support CathetersReflow Medical, Inc.20201—
+5K191560Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP CatheterVascular Solutions, LLC20191—
+5K183353Telescope Guide Extension CatheterMedtronic, Inc.20193—
+5K180088TrapLiner catheterVascular Solutions, Inc.20180—
+5K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+5K151981Turnpike catheterVascular Solution, Inc.20152—
+5K151880Wingman Crossing CatheterReflow Medical20150—
+5K141547Wingman Extendable Tip Support CatheterReflow Medical20142Class I
+5K120273Kittycat Catheter, Kittycat 2 CatheterAvinger, Inc.20120—
+5K112579Wildcat 5F Guidewire Support CatheterAvinger, Inc.20111—
+5K111338Wildcat CatheterAvinger, Inc.201117—
+6K260559NHanceITIMDS Operation B.V.20260—
+6K252390Telescope Guide Extension CatheterMedtronic, Ireland20250—
+6K251277CoraForce Microcatheter, CoraFlex MicrocatheterReflow Medical, Inc.20250—
+6K242337FlowGuide (FG60F); GuidionShort (GS60F)Imds Operations B.V.20250—
+6K243691LiquID .051 LP Guide Catheter ExtensionSeigla Medical, Inc.20250—
+6K242276CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)Vantis Vascular, Inc.20241—
+6K173661Wingman 35 Crossing CatheterReflow Medical, Inc.20180—
+6K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—
+6K122380Ocelot SystemAvinger, Inc.201214—
+6K113838Wildcat CatheterAvinger, Inc.20120—
+7K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.20260—
+7K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+7K123532Ocelot Pixl CatheterAvinger, Inc.201212—
+7K123462Ocelot CatheterAvinger, Inc.20120—
+8K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+8K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+8K152275Pantheris SystemAvinger, Inc.20156—
+9K230005Pantheris LV Atherectomy CatheterAvinger, Inc.20230—
+9K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.20230—