510(k) K240394

multiFlux 1000 (F00012408) by Fresenius Medical Care Renal Therapies Group, LLC — Product Code KDI

K240394 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care Renal Therapies Group, LLC for the device "multiFlux 1000 (F00012408)". The FDA issued a decision of Substantially Equivalent on May 31, 2024. 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 at least 10 other 510(k) clearances on record.