510(k) Report

Devices descending from K001435

108 later devices reach Viking Optima Guiding Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K011562Lumend Percutaneous CatheterLumend, Inc.2002105—
+1K013638Modification to Viking Optima Guiding CatheterGuidant Corp.20010—
+1K012002Viking Optima Guiding CatheterGuidant Corp.20010—
+2K081130Bridgepoint Medical Crossboss Percutaneous Coronary CatheterBridgepoint Medical200914—
+2K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical2009241
+2K052258Vascular Solutions Skyway Support CatheterVascular Solutions, Inc.200580—
+3K121763Multicross Support CatheterRoxwood Medical, Inc.20128—
+3K113589Bigboss CatheterBridgepoint Medical20126—
+3K111963Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical20117—
+3K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+3K101591Stingray Orienting Balloon CatheterBridgepoint Medical2010141
+3K091841Bridgepoint Medical Crossboss Catheter, Model M-2000Bridgepoint Medical200913—
+3K082337Minnie Support CatheterVascular Solutions, Inc.200935—
+3K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610Vascular Solutions, Inc.200744—
+4K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+4K152957MultiCross CatheterRoxwood Medical, Inc.20160—
+4K152401Stingray LP CatheterBoston Scientific Corporation20151—
+4K143608NovaCross MicrocatheterNitiloop, Ltd.20152—
+4K140910Centercross CatheterRoxwood Medical, Inc.20143—
+4K141649Spex Support CatheterReflow Medical20146—
+4K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+4K130714Progigy Support CatheterRadius Medical, LLC20134—
+4K123311Qxmedical Access & Support CatheterQxmedical, LLC20134—
+4K122795Stingray GuidewiresBridgepoint Medical201201
+4K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+4K120129Mantaray CatheterBridgepoint Medical20126—
+4K101117Lev-or Dilation Catheter OtwBaylis Medical Co., Inc.20100—
+4K091750Guideliner Catheter, Models 5571, 5572, 5573Vascular Solutions, Inc.200914—
+4K092299Trailblazer Support CatheterEv3, Inc.200921
+4K091345Gopher Gold Catheter, Model 5620Vascular Solutions, Inc.200920—
+4K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc.200921—
+5K231176Stingray LP CatheterBoston Scientific20230—
+5K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+5K200317Support CatheterQxmedical, LLC20200—
+5K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+5K183357XableCath Crossing CatheterXablecath, Inc.20190—
+5K173662speX Support CatheterReflow Medical, Inc.20175—
+5K170914TXM Support CatheterTexasmedical Technologies, Inc.20170—
+5K172297NovaCross MicrocatheterNitiloop, Ltd.20170—
+5K170041XableCath Support CatheterXablecath, Inc.20171—
+5K160561Boosting CatheterQxmedical, LLC20160—
+5K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.)20160—
+5K160848Wingman 18 Crossing CatheterReflow Medical, Inc.20163—
+5K160389NovaCross MicrocatheterNitiloop, Ltd.20161—
+5K152456CenterCross Ultra CatheterRoxwood Medical, Inc.20162—
+5K142065Turnpike CatheterVascular Solutions, Inc.20144—
+5K121745Mantaray GuidewiresBridgepoint Medical20120—
+5K112100M2 Navigation Catheter and Guideliner Navigation CatheterVascular Solutions, Inc.20120—
+5K112082Guideliner V2 CatheterVascular Solutions, Inc.2011121
+5K101659Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM) Model 5300, 5301Vascular Solutions, Inc.201041
+5K101479Wingman Extendable Tip Support CatheterReflow Medical20105—
+5K101647Wildcat 5F Guidewire Support Catheter, Mode W500Avinger, Inc.20102—
+5K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc.201018—
+6K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+6K214106QuikPass CatheterTraverse Vascular, Inc.20220—
+6K211240ViperCross Support CathetersCardiovascular Systems, Inc.20211—
+6K210647SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterVascular Solutions, LLC20210—
+6K200094speX LP Support CatheterReflow Medical20201—
+6K193012speX Support CatheterReflow Medical20202—
+6K191560Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP CatheterVascular Solutions, LLC20191—
+6K180986XableCath Support Catheter Product FamilyXablecath, Inc.20180—
+6K172090GuideLiner V3 CatheterVascular Solutions, Inc.20178—
+6K170996Wingman 14C Crossing CatheterReflow Medical, Inc.20172—
+6K161901TrapLiner catheterVascular Solutions, Inc.20171—
+6K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+6K151981Turnpike catheterVascular Solution, Inc.20152—
+6K120707Switch-IT CatheterVascular Solutions, Inc.20120—
+6K120273Kittycat Catheter, Kittycat 2 CatheterAvinger, Inc.20120—
+6K120178Wingman Extendable Tip Support CatheterReflow Medical20124—
+6K112579Wildcat 5F Guidewire Support CatheterAvinger, Inc.20111—
+6K111338Wildcat CatheterAvinger, Inc.201117—
+7K260559NHanceITIMDS Operation B.V.20260—
+7K233350SINC Support CatheterReflow Medical, Inc.20240—
+7K220691LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter ExtensionSeigla Medical, Inc.20221—
+7K212725ViperCross Support CathetersCardiovascular Systems, Inc.20210—
+7K210110GuidionImds Operations B.V.20211—
+7K201811coraForce and coraFlex Support CathetersReflow Medical, Inc.20201—
+7K190393Wingman 14C Crossing CatheterReflow Medical, Inc.20191—
+7K183353Telescope Guide Extension CatheterMedtronic, Inc.20193—
+7K180088TrapLiner catheterVascular Solutions, Inc.20180—
+7K170403CenterCross Ultra LV CatheterRoxwood Medical, Inc.20170—
+7K132420Wingman Extendable Tip Support CatheterReflow Medical20133—
+7K122380Ocelot SystemAvinger, Inc.201214—
+7K113838Wildcat CatheterAvinger, Inc.20120—
+8K252390Telescope Guide Extension CatheterMedtronic, Ireland20250—
+8K251277CoraForce Microcatheter, CoraFlex MicrocatheterReflow Medical, Inc.20250—
+8K242337FlowGuide (FG60F); GuidionShort (GS60F)Imds Operations B.V.20250—
+8K243691LiquID .051 LP Guide Catheter ExtensionSeigla Medical, Inc.20250—
+8K242276CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)Vantis Vascular, Inc.20241—
+8K210188coraCrossReflow Medical20210—
+8K151880Wingman Crossing CatheterReflow Medical20150—
+8K141547Wingman Extendable Tip Support CatheterReflow Medical20142Class I
+8K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+8K123532Ocelot Pixl CatheterAvinger, Inc.201212—
+8K123462Ocelot CatheterAvinger, Inc.20120—
+9K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.20260—
+9K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+9K173661Wingman 35 Crossing CatheterReflow Medical, Inc.20180—
+9K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+9K152275Pantheris SystemAvinger, Inc.20156—