510(k) Report

Devices descending from K801113

4 later devices reach Dilator, Vessel, for Perc. Catheter. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162389Medcomp Vessel DilatorMedcomp ( Medical Components)20173—
+2K192283MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F…Medron, LLC20200—
+2K183036Dilator SetsCook Incorporated201813
+3K210734Endovascular Dilator and SetsCook Incorporated20210—