510(k) Report

Devices descending from K091582

10 later devices reach GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140695Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition…Medtronic, Inc.20140—
+1K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies20117—
+1K100470GTX 12 GidewireMedtronic, Inc.20101Class I
+2K142415Hi-Torque JET Guide Wire FamilyAbbott Vascular, Inc.20140—
+2K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc.20126—
+3K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20241—
+3K191502Heraeus Peripheral GuidewireHeraeus Medical Components, LLC20190—
+3K172073Hi-Torque Command 18 Guide WireAbbott Vascular20170—
+3K152404Hi-Torque Command 18 Guide WireAbbott Vascular20151—
+4K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20250—