510(k) Report

Devices descending from K101011

4 later devices reach HI-Torque Balance Middleweight Universal through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152709HI-Torque BalanceAbbott Vascular20152—
+1K121398Charlie Guidewire (Regular), Charlie Guidewire (Stiff)Guidepath Medical, Inc.20120Class I
+2K182553Inno-PathwireSuzhou Innomed Medical Device Co., Ltd.20190—
+2K173052Heraeus TMW GuidewireHeraeus Medical Components, LLC20170—