510(k) Report

Devices descending from K080144

3 later devices reach Mandrel Guidewires or M-Wires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140485Mandrel GuidewireLake Region Medical20142—
+2K142393Predicate Iii GuidewireLake Region Medical20141—
+3K241784Arrow® Nitinol WireTeleflex Medical20240—