510(k) K233557

HemoCare Hemodialysis System by Deka Research and Development — Product Code KDI

K233557 is an FDA 510(k) premarket notification submitted by Deka Research and Development for the device "HemoCare Hemodialysis System". The FDA issued a decision of Substantially Equivalent on July 12, 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. Deka Research and Development has at least 10 other 510(k) clearances on record.