510(k) Report

Devices descending from K111943

9 later devices reach Agills PF Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243954PeriCross™ Epicardial Access KitCirca Scientific, Inc.20250—
+1K233959EPi-Ease Epicardial Access Device (EAS)AtriCure, Inc.20241—
+1K210185CardioCurve Steerable SheathTalon Surgical20211—
+1K191546Epicardial Access SystemBaylis Medical Company, Inc.20191—
+1K142245EpiAccess SystemEpiep, Inc.20141—
+2K243928ViaOne Epicardial Access SystemCardiovia, Ltd.20250—
+2K240004CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath…Circa Scientific, Inc.20240—
+2K213582Epicardial Access SystemBaylis Medical Company, Inc.20220—
+2K170831EpiAccess SystemEpiep, Inc.20170—