510(k) Report

Devices descending from K031678

3 later devices reach HI-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152709HI-Torque BalanceAbbott Vascular20152—
+2K182553Inno-PathwireSuzhou Innomed Medical Device Co., Ltd.20190—
+2K173052Heraeus TMW GuidewireHeraeus Medical Components, LLC20170—