510(k) Report

Devices descending from K091345

20 later devices reach Gopher Gold Catheter, Model 5620 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160848Wingman 18 Crossing CatheterReflow Medical, Inc.20163—
+1K142065Turnpike CatheterVascular Solutions, Inc.20144—
+1K101659Supercross Microcatheter (130 CM), Supercross Microcatheter (150 CM) Model 5300, 5301Vascular Solutions, Inc.201041
+1K101479Wingman Extendable Tip Support CatheterReflow Medical20105—
+2K214106QuikPass CatheterTraverse Vascular, Inc.20220—
+2K211240ViperCross Support CathetersCardiovascular Systems, Inc.20211—
+2K210647SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterVascular Solutions, LLC20210—
+2K191560Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP CatheterVascular Solutions, LLC20191—
+2K170996Wingman 14C Crossing CatheterReflow Medical, Inc.20172—
+2K151981Turnpike catheterVascular Solution, Inc.20152—
+2K120707Switch-IT CatheterVascular Solutions, Inc.20120—
+2K120178Wingman Extendable Tip Support CatheterReflow Medical20124—
+3K260559NHanceITIMDS Operation B.V.20260—
+3K212725ViperCross Support CathetersCardiovascular Systems, Inc.20210—
+3K190393Wingman 14C Crossing CatheterReflow Medical, Inc.20191—
+3K132420Wingman Extendable Tip Support CatheterReflow Medical20133—
+4K210188coraCrossReflow Medical20210—
+4K151880Wingman Crossing CatheterReflow Medical20150—
+4K141547Wingman Extendable Tip Support CatheterReflow Medical20142Class I
+5K173661Wingman 35 Crossing CatheterReflow Medical, Inc.20180—