510(k) Report

Devices descending from K190459

2 later devices reach Hemoflow F3 and F4 Dialyzers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242053FX CorAL 40 (F00009214); FX CorAL 50 (F00009215)Fresenius Medical Care Renal Therapies Group, LLC20251—
+2K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC20250—