510(k) Report

Devices descending from K150360

3 later devices reach TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212784TightRail Guardian Motorized Dilator SheathSpectranetics, Inc.20221—
+1K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc.20162—
+2K223472TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…Spectranetics, Inc.20220—