510(k) Report

Devices descending from K021228

22 later devices reach HI-Torque Balance, Balance Middleweight, Balance Heavyweight, Balance Trek and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152709HI-Torque BalanceAbbott Vascular20152—
+1K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc.20126—
+1K030617PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc.2003114
+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—
+2K180726Savion DLVR Guidewire, Savion FLX GuidewireBoston Scientific, Inc.20180—
+2K173052Heraeus TMW GuidewireHeraeus Medical Components, LLC20170—
+2K172073Hi-Torque Command 18 Guide WireAbbott Vascular20170—
+2K151840Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch…Boston Scientific Corporation20150—
+2K152404Hi-Torque Command 18 Guide WireAbbott Vascular20151—
+2K143587ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix…Boston Scientific Corporation201561
+2K142415Hi-Torque JET Guide Wire FamilyAbbott Vascular, Inc.20140—
+2K032183IQ Hydrophilic Guide WireBoston Scientific Corp20034—
+3K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20250—
+3K170532True Form Reshapable Guide WireMerit Medical Systems, Inc.20170—
+3K152231Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireBoston Scientific Corporation20162—
+3K040140IQ Guide WireBoston Scientific Corp200431
+4K193194CrossTorq 14 GuidewireScientia Cardio Access, LLC20190—
+4K180795JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireBoston Scientific20180—
+4K081021Kinetix Guidewire, Plus GuidewireBoston Scientific Corp20081—
+4K052783Modification to: IQ Guide Wire, Models 38950-XX. 38951-XXBoston Scientific Corp20050—