510(k) Report

Devices descending from K131935

3 later devices reach Elisio-H Hemodialyzer, Elisio-M Hemodialyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260533Elisio™-HNipro Medical Corporation20260—
+1K160444FB-U HemodialyzerNipro Medical Corporation20170—
+1K140191Elisio-H HemodialyzerNipro Medical Corporation20141—