510(k) Report

Devices descending from K073035

12 later devices reach Prelude and Prelude Pro Sheath Introducers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130791Prelude Sheath IntroducerMerit Medical Systems, Inc.20130—
+1K100799Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH201110—
+2K153197Fortress Introducer Sheath SYstemContract Medical International, GmbH201621
+2K142357DuraSheath Introducer Sheath SystemContract Medical International, GmbH20156—
+3K203179Fortress Introducer Sheath SystemContract Medical International, GmbH20200—
+3K181463DuraSheath Introducer Sheath SystemContract Medical International, GmbH20185—
+3K170616van Andel Dilatation CatheterCook Incorporated20170—
+4K221914Catapult Guide SheathContract Medical International, GmbH20222—
+4K211405Prelude Guide SheathMerit Medical Systems, Inc.202113
+5K240957Catapult Guide SheathContract Medical International, GmbH20241—
+5K223872Low Profile Companion SheathMerit Medical Systems, Inc.20230—
+6K250439Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult Guide Sheath; 4F; 45cm…Contract Medical International, GmbH20250—