510(k) K220721

FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KDI

K220721 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000". The FDA issued a decision of Substantially Equivalent on May 11, 2023. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Fresenius Medical Care Renal Therapies Group, LLC has 51 other 510(k) clearances on record.