510(k) K963659

EXEL I.V. ADMINISTRATION SET by Exel Intl. — Product Code FPA

K963659 is an FDA 510(k) premarket notification submitted by Exel Intl. for the device "EXEL I.V. ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on December 16, 1997. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Exel Intl. has at least 10 other 510(k) clearances on record.