510(k) K052432

MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2 by Medtronic Minimed — Product Code FPA

K052432 is an FDA 510(k) premarket notification submitted by Medtronic Minimed for the device "MEDTRONIC MINIMED PARADIGM LEAPFROG II INFUSION SET, MODELS MMT-802S1, MMT-802L1, MMT-802S2, MMT-802L2". The FDA issued a decision of Substantially Equivalent on November 29, 2005. 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.