510(k) K221121

Volumat Polyethylene I.V. Administration Set by Fresenius Kabi — Product Code FPA

K221121 is an FDA 510(k) premarket notification submitted by Fresenius Kabi for the device "Volumat Polyethylene I.V. Administration Set". The FDA issued a decision of Substantially Equivalent on June 16, 2023. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Fresenius Kabi has at least 10 other 510(k) clearances on record.