510(k) Report

Devices descending from K162389

3 later devices reach Medcomp Vessel Dilator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192283MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F…Medron, LLC20200—
+1K183036Dilator SetsCook Incorporated201813
+2K210734Endovascular Dilator and SetsCook Incorporated20210—