510(k) Report

Devices descending from K973494

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152709HI-Torque BalanceAbbott Vascular20152—
+1K103101HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies201113—
+1K030617PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc.2003114
+1K013833HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating…Guidant Corp.200226—
+1K982272Galeo HS 014 Model 117 130, Galeo S 014 Model 115 488, Galeao M 014 Model 114156, Galeo…Biotronik, Inc.19992—
+1K980294Acs HI-Torque Super Sport Guide Wire with Hydrocoat Hydrophilic CoatingGuidant Corp.19980—
+2K182553Inno-PathwireSuzhou Innomed Medical Device Co., Ltd.20190—
+2K180726Savion DLVR Guidewire, Savion FLX GuidewireBoston Scientific, Inc.20180—
+2K173052Heraeus TMW GuidewireHeraeus Medical Components, LLC20170—
+2K151840Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch…Boston Scientific Corporation20150—
+2K143587ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix…Boston Scientific Corporation201561
+2K141782HI-Torque Versaturn Guide WireAbbott Vascular20141—
+2K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc.20126—
+2K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies20117—
+2K101011HI-Torque Balance Middleweight UniversalAbbott Vascular, Inc.20104—
+2K100710Roll-X GuidewireSt Jude Medical20100—
+2K090193Conductor Coronary GuidewireConcert Medical, LLC20090—
+2K082304Roll-X GuidewireSt Jude Medical20082—
+2K072460HI-Torque Balance Middleweight Universal II Guide WireAbbott Vascular, Inc.200821—
+2K042373Galeo Focus Guide WireBiotronik, Inc.20050—
+2K031678HI-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic CoatingGuidant Corp.20033—
+2K032183IQ Hydrophilic Guide WireBoston Scientific Corp20034—
+3K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20241—
+3K191502Heraeus Peripheral GuidewireHeraeus Medical Components, LLC20190—
+3K173795HI-TORQUE TurnTrac Guide Wire FamilyAbbott Vascular20180—
+3K172073Hi-Torque Command 18 Guide WireAbbott Vascular20170—
+3K170532True Form Reshapable Guide WireMerit Medical Systems, Inc.20170—
+3K152231Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireBoston Scientific Corporation20162—
+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
+3K101729Neowire Pta/Ptca GuidewireNeometrics, Inc.20100—
+3K091825HI-Torque Progress Guide Wire FamilyAbbott Vascular, Inc.20099—
+3K040140IQ Guide WireBoston Scientific Corp200431
+4K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20250—
+4K193194CrossTorq 14 GuidewireScientia Cardio Access, LLC20190—
+4K180795JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireBoston Scientific20180—
+4K123067Progress Guide Wire Family, Pilot Guide Wire FamilyAbbott Vascular, Inc.20132—
+4K101648HI-Torque Winn Guide Wire FamilyAbbott Vascular, Inc.20100—
+4K081021Kinetix Guidewire, Plus GuidewireBoston Scientific Corp20081—
+4K052783Modification to: IQ Guide Wire, Models 38950-XX. 38951-XXBoston Scientific Corp20050—
+5K193126HI-TORQUE InfilTrac Guide Wire FamilyAbbott Vascular20191—
+6K201834HI-TORQUE PROCEED Guide Wire FamilyAbbott Vascular20200—