510(k) K173879

MiniMed Mio Advance infusion set by Unomedical A/S — Product Code FPA

K173879 is an FDA 510(k) premarket notification submitted by Unomedical A/S for the device "MiniMed Mio Advance infusion set". The FDA issued a decision of Substantially Equivalent on March 5, 2018. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Unomedical A/S has at least 10 other 510(k) clearances on record.