510(k) K220312

Polyfusion IV Administration Sets by Poly Medicure Limited — Product Code FPA

K220312 is an FDA 510(k) premarket notification submitted by Poly Medicure Limited for the device "Polyfusion IV Administration Sets". The FDA issued a decision of Substantially Equivalent on April 12, 2023. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Poly Medicure Limited has at least 5 other 510(k) clearances on record.