510(k) Report

Devices descending from K152709

2 later devices reach HI-Torque Balance through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182553Inno-PathwireSuzhou Innomed Medical Device Co., Ltd.20190—
+1K173052Heraeus TMW GuidewireHeraeus Medical Components, LLC20170—