510(k) Report

Devices descending from K001969

11 later devices reach GT2 Fusion Guide Wire, Model NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091582GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15Medtronic Vascular200910Class I
+2K140695Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition…Medtronic, Inc.20140—
+2K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies20117—
+2K100470GTX 12 GidewireMedtronic, Inc.20101Class I
+3K142415Hi-Torque JET Guide Wire FamilyAbbott Vascular, Inc.20140—
+3K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc.20126—
+4K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20241—
+4K191502Heraeus Peripheral GuidewireHeraeus Medical Components, LLC20190—
+4K172073Hi-Torque Command 18 Guide WireAbbott Vascular20170—
+4K152404Hi-Torque Command 18 Guide WireAbbott Vascular20151—
+5K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20250—