510(k) Report

Devices descending from K070372

44 later devices reach Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101117Lev-or Dilation Catheter OtwBaylis Medical Co., Inc.20100—
+1K091345Gopher Gold Catheter, Model 5620Vascular Solutions, Inc.200920—
+1K083313Wildcat 7F Guidewire Support CatheterAvinger, Inc.200921—
+2K160848Wingman 18 Crossing CatheterReflow Medical, Inc.20163—
+2K142065Turnpike CatheterVascular Solutions, Inc.20144—
+2K101659Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM) Model 5300, 5301Vascular Solutions, Inc.201041
+2K101479Wingman Extendable Tip Support CatheterReflow Medical20105—
+2K101647Wildcat 5F Guidewire Support Catheter, Mode W500Avinger, Inc.20102—
+2K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SAvinger, Inc.201018—
+3K214106QuikPass CatheterTraverse Vascular, Inc.20220—
+3K211240ViperCross Support CathetersCardiovascular Systems, Inc.20211—
+3K210647SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterVascular Solutions, LLC20210—
+3K191560Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP CatheterVascular Solutions, LLC20191—
+3K170996Wingman 14C Crossing CatheterReflow Medical, Inc.20172—
+3K151981Turnpike catheterVascular Solution, Inc.20152—
+3K120707Switch-IT CatheterVascular Solutions, Inc.20120—
+3K120273Kittycat Catheter, Kittycat 2 CatheterAvinger, Inc.20120—
+3K120178Wingman Extendable Tip Support CatheterReflow Medical20124—
+3K112579Wildcat 5F Guidewire Support CatheterAvinger, Inc.20111—
+3K111338Wildcat CatheterAvinger, Inc.201117—
+4K260559NHanceITIMDS Operation B.V.20260—
+4K212725ViperCross Support CathetersCardiovascular Systems, Inc.20210—
+4K190393Wingman 14C Crossing CatheterReflow Medical, Inc.20191—
+4K132420Wingman Extendable Tip Support CatheterReflow Medical20133—
+4K122380Ocelot SystemAvinger, Inc.201214—
+4K113838Wildcat CatheterAvinger, Inc.20120—
+5K210188coraCrossReflow Medical20210—
+5K151880Wingman Crossing CatheterReflow Medical20150—
+5K141547Wingman Extendable Tip Support CatheterReflow Medical20142Class I
+5K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+5K123532Ocelot Pixl CatheterAvinger, Inc.201212—
+5K123462Ocelot CatheterAvinger, Inc.20120—
+6K201330Tigereye CTO-Crossing CatheterAvinger, Inc.20203—
+6K173661Wingman 35 Crossing CatheterReflow Medical, Inc.20180—
+6K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+6K152275Pantheris SystemAvinger, Inc.20156—
+7K230005Pantheris LV Atherectomy CatheterAvinger, Inc.20230—
+7K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.20230—
+7K212468Tigereye CTO-Crossing CatheterAvinger, Inc.20220—
+7K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+7K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+8K173862Pantheris SystemAvinger, Inc.20181—
+8K160827Pantheris CatheterAvinger, Inc.20164—
+9K212047Pantheris SystemAvinger, Inc.20210—