510(k) Report

Devices descending from K140047

7 later devices reach Lexiconture Mechanical Dilator Sheath Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211679Xtractor deviceXcardia Innovation, Ltd.20220—
+1K142546TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathSpectranetics, Inc.20145—
+1K141131Tightrail MiniSpectranetics, Inc.20146—
+2K161333TightRail Sub-C Rotating Dilator SheathSpectranetics, Inc.20162—
+2K150360TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator SheathSpectranetics, Inc.20153—
+3K212784TightRail Guardian Motorized Dilator SheathSpectranetics, Inc.20221—
+4K223472TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…Spectranetics, Inc.20220—