510(k) Report

Devices descending from K161659

1 later device reach FlexSeal Introducer Sheath with Hydrophilic Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190628FlexSeal Introducer Sheath with Hydrophilic CoatingFreudenberg Medical Mis, Inc.201902