510(k) Report

Devices descending from K103101

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152709HI-Torque BalanceAbbott Vascular20152—
+1K141782HI-Torque Versaturn Guide WireAbbott Vascular20141—
+1K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc.20126—
+1K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies20117—
+2K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20241—
+2K191502Heraeus Peripheral GuidewireHeraeus Medical Components, LLC20190—
+2K182553Inno-PathwireSuzhou Innomed Medical Device Co., Ltd.20190—
+2K173795HI-TORQUE TurnTrac Guide Wire FamilyAbbott Vascular20180—
+2K173052Heraeus TMW GuidewireHeraeus Medical Components, LLC20170—
+2K172073Hi-Torque Command 18 Guide WireAbbott Vascular20170—
+2K152404Hi-Torque Command 18 Guide WireAbbott Vascular20151—
+2K142415Hi-Torque JET Guide Wire FamilyAbbott Vascular, Inc.20140—
+3K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20250—