510(k) K190816

Vial Adapter Ø20 mm , Vial Adapter Ø13 mm by Avenir Performance Europeenne Medical (Apem) — Product Code LHI

K190816 is an FDA 510(k) premarket notification submitted by Avenir Performance Europeenne Medical (Apem) for the device "Vial Adapter Ø20 mm , Vial Adapter Ø13 mm". The FDA issued a decision of Substantially Equivalent on Nov 19, 2019. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Avenir Performance Europeenne Medical (Apem) has 1 other 510(k) clearance on record.