510(k) K223101

BD Secondary Infusion Set by Care Fusion — Product Code FPA

K223101 is an FDA 510(k) premarket notification submitted by Care Fusion for the device "BD Secondary Infusion Set". The FDA issued a decision of Substantially Equivalent on May 12, 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.