510(k) Report

Devices descending from K020340

32 later devices reach Modification to HI-Torque Whisper LS and MS Guide Wires with Hydrocoat… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030549HI-Torque Pilot 50 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque Pilot 150…Guidcorp200318—
+1K030019Modification to HI-Torque Whisper GuidewireGuidant Corp.200310—
+1K023300HI-Torque Whisper LS; HI-Torque Whisper MS; HI-Torque Whisper MS CS-J; HI-Torque Whisper…Guidant Corp.20021—
+2K123067Progress Guide Wire Family, Pilot Guide Wire FamilyAbbott Vascular, Inc.20132—
+2K101116HI-Torque Pilot 50 and 150 Guide Wire with Hydrocoat Hydrophilic Coating, HI-Torque…Abbott Vascular-Cardiac Therapies201010—
+2K091825HI-Torque Progress Guide Wire FamilyAbbott Vascular, Inc.20099—
+2K083094Streamer Polymer GuidewireBrivant, Ltd.20093—
+2K082935Vision Wire Coronary GuidewireBiotronik, Inc.20080—
+2K063210Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488Medtronic Inc. Cardiac Rhythm Management20071Class I
+2K061453HI-Torque Whisper View Guide WireGuidant Corp.20063—
+2K041762Finishing Wire SupportrakGuidant Corporation20040—
+3K193126HI-TORQUE InfilTrac Guide Wire FamilyAbbott Vascular20191—
+3K143316Attain Hybrid Guide WireMedtronic, Inc.20150—
+3K141831Hydraview GuidewireBrivant Limited20140—
+3K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc.20126—
+3K103377Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd.20112—
+3K110479Acuity Whisper View Guide WiresBoston Scientific Corp20110—
+3K101648HI-Torque Winn Guide Wire FamilyAbbott Vascular, Inc.20100—
+3K101011HI-Torque Balance Middleweight UniversalAbbott Vascular, Inc.20104—
+3K090554Acuity Mailman and Strait-Trak GuidewireBoston Scientific Corp20091—
+4K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20241—
+4K201834HI-TORQUE PROCEED Guide Wire FamilyAbbott Vascular20200—
+4K191502Heraeus Peripheral GuidewireHeraeus Medical Components, LLC20190—
+4K172073Hi-Torque Command 18 Guide WireAbbott Vascular20170—
+4K152709HI-Torque BalanceAbbott Vascular20152—
+4K152404Hi-Torque Command 18 Guide WireAbbott Vascular20151—
+4K142415Hi-Torque JET Guide Wire FamilyAbbott Vascular, Inc.20140—
+4K121398Charlie Guidewire (Regular), Charlie Guidewire (Stiff)Guidepath Medical, Inc.20120Class I
+4K122856Charter GuidewireBrivant, Ltd.20120—
+5K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20250—
+5K182553Inno-PathwireSuzhou Innomed Medical Device Co., Ltd.20190—
+5K173052Heraeus TMW GuidewireHeraeus Medical Components, LLC20170—