510(k) K770589

FILTER, INTRAVENOUS W/AUTO AIR VENT by Jelco Laboratories — Product Code FPA

K770589 is an FDA 510(k) premarket notification submitted by Jelco Laboratories for the device "FILTER, INTRAVENOUS W/AUTO AIR VENT". The FDA issued a decision of Substantially Equivalent on May 23, 1977. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Jelco Laboratories has at least 10 other 510(k) clearances on record.