510(k) Report

Devices descending from K161333

2 later devices reach TightRail Sub-C Rotating Dilator Sheath through their predicates, nearest generation first.

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