510(k) Report

Devices descending from K140485

2 later devices reach Mandrel Guidewire through their predicates, nearest generation first.

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