510(k) Report

Devices descending from K212784

1 later device reach TightRail Guardian Motorized Dilator Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223472TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…Spectranetics, Inc.20220—