510(k) K231406

ClearumTM HS by Bellco Srl — Product Code KDI

K231406 is an FDA 510(k) premarket notification submitted by Bellco Srl for the device "ClearumTM HS". The FDA issued a decision of Substantially Equivalent on June 14, 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. Bellco Srl has at least 2 other 510(k) clearances on record.