510(k) Report

Devices descending from K071496

2 later devices reach Icath, Sterilesure through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103043Colorado Catheter Sterilesure - New Name Perfic CathAdapta Medical, Inc.20111—
+2K161445PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro CAdapta Medical, Inc.20160—