510(k) K940897

IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET by Y — Product Code FPA

K940897 is an FDA 510(k) premarket notification submitted by Y for the device "IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on June 22, 1994. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Y has at least 10 other 510(k) clearances on record.