510(k) Report

Devices descending from K080863

12 later devices reach Traxcess 0.014 Hydrophilic Guidewire through their predicates, nearest generation first.

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