510(k) Report

Devices descending from K121161

3 later devices reach Empty Eva Solution Container Empty Eva Dual Chamber Solution Container through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193528Empty EVA BagHaemotronic S.P.A.20202—
+2K210749Empty EVA BagHaemotronic S.P.A.20211—
+3K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AG20260—