510(k) Report

Devices descending from DEN190042

1 later device reach Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261399Elisio™-HXNipro Medical Corporation20260—