510(k) Report

Devices descending from K153197

2 later devices reach Fortress Introducer Sheath SYstem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203179Fortress Introducer Sheath SystemContract Medical International, GmbH20200—
+1K170616van Andel Dilatation CatheterCook Incorporated20170—