510(k) K902221

MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE by Mallinckrodt Group, Inc. — Product Code DXT

K902221 is an FDA 510(k) premarket notification submitted by Mallinckrodt Group, Inc. for the device "MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE". The FDA issued a decision of Substantially Equivalent on August 8, 1990. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Mallinckrodt Group, Inc. has at least 10 other 510(k) clearances on record.