510(k) Report

Devices descending from K004046

1 later device reach Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092315Sorin VVR 4000I and 4000I Smarxt Filtered Hardshell Venous ReservoirSorin Group Italia S.R.L.20090—