510(k) K984088

OPTISTAR MR INJECTOR SYSTEM by Mallinckrodt Inc., Liebel-Flarsheim Business — Product Code DXT

K984088 is an FDA 510(k) premarket notification submitted by Mallinckrodt Inc., Liebel-Flarsheim Business for the device "OPTISTAR MR INJECTOR SYSTEM". The FDA issued a decision of Substantially Equivalent on December 6, 1999. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Mallinckrodt Inc., Liebel-Flarsheim Business has at least 7 other 510(k) clearances on record.