510(k) K042172

CLEO 90 INFUSION SET by Smiths Medical MD, Inc. — Product Code FPA

K042172 is an FDA 510(k) premarket notification submitted by Smiths Medical MD, Inc. for the device "CLEO 90 INFUSION SET". The FDA issued a decision of Substantially Equivalent on October 7, 2004. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Smiths Medical MD, Inc. has at least 10 other 510(k) clearances on record.