510(k) Report

Devices descending from K913353

55 later devices reach Vascular Guide Wire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984394Acs HI-Torque Wiggle Guide Wire with Microglide CoatingGuidant Corp.19990—
+1K971815Asc Balance Middleweight Guide WireGuidant Corp.199753—
+2K152709HI-Torque BalanceAbbott Vascular20152—
+2K103101HI-Torque Balance Middleweight EliteAbbott Vascular-Cardiac Therapies201113—
+2K030617PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc.2003114
+2K021363Endovascular Guide WireStereotaxis, Inc.200286
+2K973494HI-Torque Balance Guide Wire with Hydrocoat Hydrophilic Coating, Acs HI-Torque Balance…Guidant Corp.199743—
+3K182553Inno-PathwireSuzhou Innomed Medical Device Co., Ltd.20190—
+3K180726Savion DLVR Guidewire, Savion FLX GuidewireBoston Scientific, Inc.20180—
+3K173052Heraeus TMW GuidewireHeraeus Medical Components, LLC20170—
+3K151840Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch…Boston Scientific Corporation20150—
+3K143587ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix…Boston Scientific Corporation201561
+3K141782HI-Torque Versaturn Guide WireAbbott Vascular20141—
+3K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc.20126—
+3K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies20117—
+3K043457Modification to Endovascular Guide WireStereotaxis, Inc.20051—
+3K042854Stereotaxis Endovascular Guide WireStereotaxis, Inc.20056—
+3K032183IQ Hydrophilic Guide WireBoston Scientific Corp20034—
+3K013833HI-Toque Balance Middleweight Universal Guide Wire with Hydrocoat Hydrophilic Coating…Guidant Corp.200226—
+3K982272Galeo HS 014 Model 117 130, Galeo S 014 Model 115 488, Galeao M 014 Model 114156, Galeo…Biotronik, Inc.19992—
+3K980294Acs HI-Torque Super Sport Guide Wire with Hydrocoat Hydrophilic CoatingGuidant Corp.19980—
+4K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20241—
+4K191502Heraeus Peripheral GuidewireHeraeus Medical Components, LLC20190—
+4K173795HI-TORQUE TurnTrac Guide Wire FamilyAbbott Vascular20180—
+4K172073Hi-Torque Command 18 Guide WireAbbott Vascular20170—
+4K170532True Form Reshapable Guide WireMerit Medical Systems, Inc.20170—
+4K152231Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireBoston Scientific Corporation20162—
+4K152404Hi-Torque Command 18 Guide WireAbbott Vascular20151—
+4K142415Hi-Torque JET Guide Wire FamilyAbbott Vascular, Inc.20140—
+4K101011HI-Torque Balance Middleweight UniversalAbbott Vascular, Inc.20104—
+4K100710Roll-X GuidewireSt Jude Medical20100—
+4K090193Conductor Coronary GuidewireConcert Medical, LLC20090—
+4K082304Roll-X GuidewireSt Jude Medical20082—
+4K080637Powerasset Radiofrequency Guidwire, Model VariousStereotaxis, Inc.20080—
+4K080364Findrwirz Guide Wire SystemSentreheart, Inc.20080Class I
+4K072460HI-Torque Balance Middleweight Universal II Guide WireAbbott Vascular, Inc.200821—
+4K052347Titan Steerable (Ptca) GuidewireLake Region Mfg., Inc.20062—
+4K051373Cronus Guidewire, Model 001-001470-1Stereotaxis, Inc.20050—
+4K042373Galeo Focus Guide WireBiotronik, Inc.20050—
+4K040140IQ Guide WireBoston Scientific Corp200431
+4K031678HI-Torque Balance Iniversal Guide Wire with Hydrocoat Hydrophilic CoatingGuidant Corp.20033—
+5K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20250—
+5K193194CrossTorq 14 GuidewireScientia Cardio Access, LLC20190—
+5K180795JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireBoston Scientific20180—
+5K121398Charlie Guidewire (Regular), Charlie Guidewire (Stiff)Guidepath Medical, Inc.20120Class I
+5K101729Neowire Pta/Ptca GuidewireNeometrics, Inc.20100—
+5K091825HI-Torque Progress Guide Wire FamilyAbbott Vascular, Inc.20099—
+5K081021Kinetix Guidewire, Plus GuidewireBoston Scientific Corp20081—
+5K060454Titan GuidewireLake Region Mfg., Inc.20061—
+5K052783Modification to: IQ Guide Wire, Models 38950-XX. 38951-XXBoston Scientific Corp20050—
+6K123067Progress Guide Wire Family, Pilot Guide Wire FamilyAbbott Vascular, Inc.20132—
+6K101648HI-Torque Winn Guide Wire FamilyAbbott Vascular, Inc.20100—
+6K073655Pegasus Steerable (Ptca) GuidewireLake Region Mfg., Inc.20080—
+7K193126HI-TORQUE InfilTrac Guide Wire FamilyAbbott Vascular20191—
+8K201834HI-TORQUE PROCEED Guide Wire FamilyAbbott Vascular20200—