510(k) K845037

PERCUTANEOUS ANGIOGRAPHIC NEEDLES by Mallinckrodt Critical Care — Product Code DYB

K845037 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "PERCUTANEOUS ANGIOGRAPHIC NEEDLES". The FDA issued a decision of Substantially Equivalent on June 21, 1985. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Mallinckrodt Critical Care has at least 10 other 510(k) clearances on record.