510(k) K862653

LUER LOCK ADAPTER/NUT by Mallinckrodt Critical Care — Product Code FPA

K862653 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "LUER LOCK ADAPTER/NUT". The FDA issued a decision of Substantially Equivalent on July 31, 1986. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Mallinckrodt Critical Care has at least 10 other 510(k) clearances on record.