510(k) Report

Devices descending from K071518

3 later devices reach Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170574Diacap Pro DialyzerB. Braun Avitum AG20170—
+1K143482xevonta dialyzerB. Braun Avitum AG20160—
+1K100334Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811B. Braun Avitum AG20101—