510(k) K880343

BURNEY GALLBLADDER CATHETER KIT by Mallinckrodt Critical Care — Product Code FGE

K880343 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "BURNEY GALLBLADDER CATHETER KIT". The FDA issued a decision of Substantially Equivalent on May 1, 1989. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Mallinckrodt Critical Care has at least 10 other 510(k) clearances on record.