510(k) K193528

Empty EVA Bag by Haemotronic S.P.A. — Product Code KPE

K193528 is an FDA 510(k) premarket notification submitted by Haemotronic S.P.A. for the device "Empty EVA Bag". The FDA issued a decision of Substantially Equivalent on July 22, 2020. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Haemotronic S.P.A. has at least 5 other 510(k) clearances on record.