510(k) Report

Devices descending from K181463

5 later devices reach DuraSheath Introducer Sheath System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221914Catapult Guide SheathContract Medical International, GmbH20222—
+1K211405Prelude Guide SheathMerit Medical Systems, Inc.202113
+2K240957Catapult Guide SheathContract Medical International, GmbH20241—
+2K223872Low Profile Companion SheathMerit Medical Systems, Inc.20230—
+3K250439Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm…Contract Medical International, GmbH20250—