510(k) Report

Devices descending from K133725

9 later devices reach Traxcess 14 Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited20260—
+1K200374Columbus GuidewireRapid-Medical, Ltd.20200—
+1K182337HYBRID GuidewireBalt USA, LLC20181—
+1K153053Traxcess Pro 14 GuidewireMicroVention, Inc.20154—
+2K252011CHIKAI Nexus petitAsahi Intecc Co., Ltd.20260—
+2K200547Traxcess 14 SELECT GuidewireMicroVention, Inc.20200—
+2K161803Traxcess .007 Mini GuidewireMicroVention, Inc.201621
+3K201487Traxcess 7 Mini GuidewireMicroVention, Inc.20200—
+3K163154Traxcess 7 Mini XSoft GuidewireMicroVention, Inc.20160—