510(k) K100432

POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS by Medtronic Minimed — Product Code FPA

K100432 is an FDA 510(k) premarket notification submitted by Medtronic Minimed for the device "POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS". The FDA issued a decision of Substantially Equivalent on July 9, 2010. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Medtronic Minimed has at least 10 other 510(k) clearances on record.