510(k) Report

Devices descending from K063695

31 later devices reach Runthrough NS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103101HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies201113—
+1K080863Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc.200812—
+1K080563Runthrough NS Extension WireTerumo Medical Corp.20085—
+2K152709HI-Torque BalanceAbbott Vascular20152—
+2K141782HI-Torque Versaturn Guide WireAbbott Vascular20141—
+2K133725Traxcess 14 GuidewireMicroVention, Inc.20149—
+2K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc.20126—
+2K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies20117—
+2K093647Traxcess Docking WireMicroVention, Inc.20102—
+2K093397Traxcess 14EX Guidewire and Traxcess Docking WireMicroVention, Inc.20091—
+3K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited20260—
+3K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20241—
+3K200374Columbus GuidewireRapid-Medical, Ltd.20200—
+3K191502Heraeus Peripheral GuidewireHeraeus Medical Components, LLC20190—
+3K191687pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension WirePhenox Limited20190—
+3K182553Inno-PathwireSuzhou Innomed Medical Device Co., Ltd.20190—
+3K182337HYBRID GuidewireBalt USA, LLC20181—
+3K173795HI-TORQUE TurnTrac Guide Wire FamilyAbbott Vascular20180—
+3K173052Heraeus TMW GuidewireHeraeus Medical Components, LLC20170—
+3K172073Hi-Torque Command 18 Guide WireAbbott Vascular20170—
+3K153053Traxcess Pro 14 GuidewireMicroVention, Inc.20154—
+3K152404Hi-Torque Command 18 Guide WireAbbott Vascular20151—
+3K142415Hi-Torque JET Guide Wire FamilyAbbott Vascular, Inc.20140—
+3K112219Tapas CatheterThermopeutix, Inc.20111—
+4K252011CHIKAI Nexus petitAsahi Intecc Co., Ltd.20260—
+4K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20250—
+4K200547Traxcess 14 SELECT GuidewireMicroVention, Inc.20200—
+4K161803Traxcess .007 Mini GuidewireMicroVention, Inc.201621
+4K141175Renovocath RC120Renovorx, Inc.201401
+5K201487Traxcess 7 Mini GuidewireMicroVention, Inc.20200—
+5K163154Traxcess 7 Mini XSoft GuidewireMicroVention, Inc.20160—