510(k) Report

Devices descending from K003874

4 later devices reach CBC-4K Hematology Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052440Mentor Self-Cath Hydrogel Intermittent CatheterMentor Corporation20053—
+2K071496Icath, SterilesureColorado Catheter Company, Inc.20072—
+3K103043Colorado Catheter Sterilesure - New Name Perfic CathAdapta Medical, Inc.20111—
+4K161445PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro CAdapta Medical, Inc.20160—