510(k) K934095

IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS by Y — Product Code FPA

K934095 is an FDA 510(k) premarket notification submitted by Y for the device "IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS". The FDA issued a decision of Substantially Equivalent on August 10, 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.