510(k) Report

Devices descending from K030549

18 later devices reach HI-Torque Pilot 50 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123067Progress Guide Wire Family, Pilot Guide Wire FamilyAbbott Vascular, Inc.20132—
+1K101116HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque…Abbott Vascular-Cardiac Therapies201010—
+1K091825HI-Torque Progress Guide Wire FamilyAbbott Vascular, Inc.20099—
+2K193126HI-TORQUE InfilTrac Guide Wire FamilyAbbott Vascular20191—
+2K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc.20126—
+2K101648HI-Torque Winn Guide Wire FamilyAbbott Vascular, Inc.20100—
+2K101011HI-Torque Balance Middleweight UniversalAbbott Vascular, Inc.20104—
+3K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20241—
+3K201834HI-TORQUE PROCEED Guide Wire FamilyAbbott Vascular20200—
+3K191502Heraeus Peripheral GuidewireHeraeus Medical Components, LLC20190—
+3K172073Hi-Torque Command 18 Guide WireAbbott Vascular20170—
+3K152709HI-Torque BalanceAbbott Vascular20152—
+3K152404Hi-Torque Command 18 Guide WireAbbott Vascular20151—
+3K142415Hi-Torque JET Guide Wire FamilyAbbott Vascular, Inc.20140—
+3K121398Charlie Guidewire (Regular), Charlie Guidewire (Stiff)Guidepath Medical, Inc.20120Class I
+4K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20250—
+4K182553Inno-PathwireSuzhou Innomed Medical Device Co., Ltd.20190—
+4K173052Heraeus TMW GuidewireHeraeus Medical Components, LLC20170—