510(k) Report

Devices descending from K011562

105 later devices reach Lumend Percutaneous Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081130Bridgepoint Medical Crossboss Percutaneous Coronary CatheterBridgepoint Medical200914—
+1K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical2009241
+1K052258Vascular Solutions Skyway Support CatheterVascular Solutions, Inc.200580—
+2K121763Multicross Support CatheterRoxwood Medical, Inc.20128—
+2K113589Bigboss CatheterBridgepoint Medical20126—
+2K111963Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical20117—
+2K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+2K101591Stingray Orienting Balloon CatheterBridgepoint Medical2010141
+2K091841Bridgepoint Medical Crossboss Catheter, Model M-2000Bridgepoint Medical200913—
+2K082337Minnie Support CatheterVascular Solutions, Inc.200935—
+2K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610Vascular Solutions, Inc.200744—
+3K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+3K152957MultiCross CatheterRoxwood Medical, Inc.20160—
+3K152401Stingray LP CatheterBoston Scientific Corporation20151—
+3K143608NovaCross MicrocatheterNitiloop, Ltd.20152—
+3K140910Centercross CatheterRoxwood Medical, Inc.20143—
+3K141649Spex Support CatheterReflow Medical20146—
+3K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+3K130714Progigy Support CatheterRadius Medical, LLC20134—
+3K123311Qxmedical Access & Support CatheterQxmedical, LLC20134—
+3K122795Stingray GuidewiresBridgepoint Medical201201
+3K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+3K120129Mantaray CatheterBridgepoint Medical20126—
+3K101117Lev-or Dilation Catheter OtwBaylis Medical Co., Inc.20100—
+3K091750Guideliner Catheter, Models 5571, 5572, 5573Vascular Solutions, Inc.200914—
+3K092299Trailblazer Support CatheterEv3, Inc.200921
+3K091345Gopher Gold Catheter, Model 5620Vascular Solutions, Inc.200920—
+3K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc.200921—
+4K231176Stingray LP CatheterBoston Scientific20230—
+4K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+4K200317Support CatheterQxmedical, LLC20200—
+4K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+4K183357XableCath Crossing CatheterXablecath, Inc.20190—
+4K173662speX Support CatheterReflow Medical, Inc.20175—
+4K170914TXM Support CatheterTexasmedical Technologies, Inc.20170—
+4K172297NovaCross MicrocatheterNitiloop, Ltd.20170—
+4K170041XableCath Support CatheterXablecath, Inc.20171—
+4K160561Boosting CatheterQxmedical, LLC20160—
+4K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.)20160—
+4K160848Wingman 18 Crossing CatheterReflow Medical, Inc.20163—
+4K160389NovaCross MicrocatheterNitiloop, Ltd.20161—
+4K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+4K142065Turnpike CatheterVascular Solutions, Inc.20144—
+4K121745Mantaray GuidewiresBridgepoint Medical20120—
+4K112100M2 Navigation Catheter and Guideliner Navigation CatheterVascular Solutions, Inc.20120—
+4K112082Guideliner V2 CatheterVascular Solutions, Inc.2011121
+4K101659Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM) Model 5300, 5301Vascular Solutions, Inc.201041
+4K101479Wingman Extendable Tip Support CatheterReflow Medical20105—
+4K101647Wildcat 5F Guidewire Support Catheter, Mode W500Avinger, Inc.20102—
+4K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc.201018—
+5K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+5K214106QuikPass CatheterTraverse Vascular, Inc.20220—
+5K211240ViperCross Support CathetersCardiovascular Systems, Inc.20211—
+5K210647SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterVascular Solutions, LLC20210—
+5K200094speX LP Support CatheterReflow Medical20201—
+5K193012speX Support CatheterReflow Medical20202—
+5K191560Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP CatheterVascular Solutions, LLC20191—
+5K180986XableCath Support Catheter Product FamilyXablecath, Inc.20180—
+5K172090GuideLiner V3 CatheterVascular Solutions, Inc.20178—
+5K170996Wingman 14C Crossing CatheterReflow Medical, Inc.20172—
+5K161901TrapLiner catheterVascular Solutions, Inc.20171—
+5K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+5K151981Turnpike catheterVascular Solution, Inc.20152—
+5K120707Switch-IT CatheterVascular Solutions, Inc.20120—
+5K120273Kittycat Catheter, Kittycat 2 CatheterAvinger, Inc.20120—
+5K120178Wingman Extendable Tip Support CatheterReflow Medical20124—
+5K112579Wildcat 5F Guidewire Support CatheterAvinger, Inc.20111—
+5K111338Wildcat CatheterAvinger, Inc.201117—
+6K260559NHanceITIMDS Operation B.V.20260—
+6K233350SINC Support CatheterReflow Medical, Inc.20240—
+6K220691LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter ExtensionSeigla Medical, Inc.20221—
+6K212725ViperCross Support CathetersCardiovascular Systems, Inc.20210—
+6K210110GuidionImds Operations B.V.20211—
+6K201811coraForce and coraFlex Support CathetersReflow Medical, Inc.20201—
+6K190393Wingman 14C Crossing CatheterReflow Medical, Inc.20191—
+6K183353Telescope Guide Extension CatheterMedtronic, Inc.20193—
+6K180088TrapLiner catheterVascular Solutions, Inc.20180—
+6K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—
+6K132420Wingman Extendable Tip Support CatheterReflow Medical20133—
+6K122380Ocelot SystemAvinger, Inc.201214—
+6K113838Wildcat CatheterAvinger, Inc.20120—
+7K252390Telescope Guide Extension CatheterMedtronic, Ireland20250—
+7K251277CoraForce Microcatheter, CoraFlex MicrocatheterReflow Medical, Inc.20250—
+7K242337FlowGuide (FG60F); GuidionShort (GS60F)Imds Operations B.V.20250—
+7K243691LiquID .051 LP Guide Catheter ExtensionSeigla Medical, Inc.20250—
+7K242276CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)Vantis Vascular, Inc.20241—
+7K210188coraCrossReflow Medical20210—
+7K151880Wingman Crossing CatheterReflow Medical20150—
+7K141547Wingman Extendable Tip Support CatheterReflow Medical20142Class I
+7K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+7K123532Ocelot Pixl CatheterAvinger, Inc.201212—
+7K123462Ocelot CatheterAvinger, Inc.20120—
+8K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.20260—
+8K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+8K173661Wingman 35 Crossing CatheterReflow Medical, Inc.20180—
+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—
+9K212468Tigereye CTO-Crossing CatheterAvinger, Inc.20220—