510(k) K061374

INTUITION INFUSION SETS by Unomedical A/S — Product Code FPA

K061374 is an FDA 510(k) premarket notification submitted by Unomedical A/S for the device "INTUITION INFUSION SETS". The FDA issued a decision of Substantially Equivalent on July 31, 2006. 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.