510(k) Report

Devices descending from K001992

158 later devices reach Ilt 0.014 Catheter, Model C114NL2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K210647SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterVascular Solutions, LLC20210—
+6K200094speX LP Support CatheterReflow Medical20201—
+6K193012speX Support CatheterReflow Medical20202—
+6K180986XableCath Support Catheter Product FamilyXablecath, Inc.20180—
+6K173560MicrocatheterSurmodics,Inc.20181—
+6K172090GuideLiner V3 CatheterVascular Solutions, Inc.20178—
+6K170996Wingman 14C Crossing CatheterReflow Medical, Inc.20172—
+6K161901TrapLiner catheterVascular Solutions, Inc.20171—
+6K160681CenterCross Ultra CatheterRoxwood Medical, Inc.20161—
+6K161362ASAHI Corsair ArmetAsahi Intecc Co., Ltd.20162—
+6K151082MicroCross CatheterRoxwood Medical, Inc.20150—
+6K130414Chocolate Pta Balloon Catheter (Over the Wire) 0.014 Guide Wire, Chocolate Pta Balloon…Trireme Medical, Inc.20131—
+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—
+7K242588COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)OrbusNeich Medical (Shenzhen) Co., Ltd.20250—
+7K233350SINC Support CatheterReflow Medical, Inc.20240—
+7K232647MicrocatheterSurmodics,Inc.20230—
+7K220691LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter ExtensionSeigla Medical, Inc.20221—
+7K213631Chocolate PTA Balloon CatheterMedtronic, Inc.20210—
+7K212725ViperCross Support CathetersCardiovascular Systems, Inc.20210—
+7K210110GuidionImds Operations B.V.20211—
+7K201811coraForce and coraFlex Support CathetersReflow Medical, Inc.20201—
+7K202252ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18…Asahi Intecc Co., Ltd.20200—
+7K192782ASAHI CROSSWALK Peripheral Support CatheterAsahi Intecc Co., Ltd.20190—
+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—
+10K230005Pantheris LV Atherectomy CatheterAvinger, Inc.20230—
+10K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.20230—
+10K212468Tigereye CTO-Crossing CatheterAvinger, Inc.20220—
+10K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+10K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+11K173862Pantheris SystemAvinger, Inc.20181—
+11K160827Pantheris CatheterAvinger, Inc.20164—
+12K212047Pantheris SystemAvinger, Inc.20210—