510(k) K041495

PENTADEFLUE IV SOLUTION ADMINISTRATION SETS by Pentaferte S.P.A — Product Code FPA

K041495 is an FDA 510(k) premarket notification submitted by Pentaferte S.P.A for the device "PENTADEFLUE IV SOLUTION ADMINISTRATION SETS". The FDA issued a decision of Substantially Equivalent on April 15, 2005. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Pentaferte S.P.A has at least 2 other 510(k) clearances on record.