510(k) K142527

Extension Set with BD Q-Syte Luer Access Split Septum by Acacia, Inc. — Product Code FPA

K142527 is an FDA 510(k) premarket notification submitted by Acacia, Inc. for the device "Extension Set with BD Q-Syte Luer Access Split Septum". The FDA issued a decision of Substantially Equivalent on September 19, 2014. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Acacia, Inc. has at least 10 other 510(k) clearances on record.