510(k) Report

Devices descending from K142546

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211679Xtractor deviceXcardia Innovation, Ltd.20220—
+1K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc.20162—
+1K150360TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator SheathSpectranetics, Inc.20153—
+2K212784TightRail Guardian Motorized Dilator SheathSpectranetics, Inc.20221—
+3K223472TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…Spectranetics, Inc.20220—