510(k) Report

Devices descending from K142357

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181463DuraSheath Introducer Sheath SystemContract Medical International, GmbH20185—
+2K221914Catapult Guide SheathContract Medical International, GmbH20222—
+2K211405Prelude Guide SheathMerit Medical Systems, Inc.202113
+3K240957Catapult Guide SheathContract Medical International, GmbH20241—
+3K223872Low Profile Companion SheathMerit Medical Systems, Inc.20230—
+4K250439Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm…Contract Medical International, GmbH20250—