510(k) Report

Devices descending from K042938

1 later device reach Gambro Prismaflex HF1000 and HF1400 Sets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220281multiFiltratePRO SystemFresenius Medical Care Renal Therapies Group, LLC20220—