510(k) K052431

MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 by Medtronic Minimed — Product Code FPK

K052431 is an FDA 510(k) premarket notification submitted by Medtronic Minimed for the device "MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1". The FDA issued a decision of Substantially Equivalent on November 29, 2005. The device falls under product code FPK (Tubing, Fluid Delivery), a Class II device regulated under 21 CFR 880.5440. Medtronic Minimed has at least 10 other 510(k) clearances on record.