510(k) K221327

BD Alaris™ Pump Infusion Sets by Care Fusion — Product Code FPA

K221327 is an FDA 510(k) premarket notification submitted by Care Fusion for the device "BD Alaris™ Pump Infusion Sets". The FDA issued a decision of Substantially Equivalent on July 21, 2023. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Care Fusion has at least 10 other 510(k) clearances on record.