510(k) Report

Devices descending from K955801

15 later devices reach Radifocus Glidewire GT with Gold Coil,Glidewire Gold through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080863Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc.200812—
+1K050873Canalizer Hydrophilic Guide WireMedical Device Technologies, Inc.20051—
+2K133725Traxcess 14 GuidewireMicroVention, Inc.20149—
+2K093397Traxcess 14EX Guidewire and Traxcess Docking WireMicroVention, Inc.20091—
+2K073672Skater Biliary CatheterAngiotech20080—
+3K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited20260—
+3K200374Columbus GuidewireRapid-Medical, Ltd.20200—
+3K191687pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension WirePhenox Limited20190—
+3K182337HYBRID GuidewireBalt USA, LLC20181—
+3K153053Traxcess Pro 14 GuidewireMicroVention, Inc.20154—
+4K252011CHIKAI Nexus petitAsahi Intecc Co., Ltd.20260—
+4K200547Traxcess 14 SELECT GuidewireMicroVention, Inc.20200—
+4K161803Traxcess .007 Mini GuidewireMicroVention, Inc.201621
+5K201487Traxcess 7 Mini GuidewireMicroVention, Inc.20200—
+5K163154Traxcess 7 Mini XSoft GuidewireMicroVention, Inc.20160—