510(k) K864338

SECONDARY SET LOCK by Travenol Laboratories, S.A. — Product Code FPA

K864338 is an FDA 510(k) premarket notification submitted by Travenol Laboratories, S.A. for the device "SECONDARY SET LOCK". The FDA issued a decision of Substantially Equivalent on November 19, 1986. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Travenol Laboratories, S.A. has at least 10 other 510(k) clearances on record.