510(k) Report

Devices descending from K081940

4 later devices reach Avalon Elite Vascular Access Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182914MC3 Vascular Access Kit 21030Mc3 Incorporated20180—
+1K162181Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc.201711
+1K120349Sonixgps Vascular Access Needle KitUltrasonix Medical Corpation20120—
+2K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.20250—