510(k) K212445

freeflex+ Transfer Adapter by Fresenius Kabi AG — Product Code LHI

K212445 is an FDA 510(k) premarket notification submitted by Fresenius Kabi AG for the device "freeflex+ Transfer Adapter". The FDA issued a decision of Substantially Equivalent on June 1, 2022. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Fresenius Kabi AG has at least 10 other 510(k) clearances on record.