510(k) K033333

SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B by Aomori Olympus Co., Ltd. — Product Code FGE

K033333 is an FDA 510(k) premarket notification submitted by Aomori Olympus Co., Ltd. for the device "SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B". The FDA issued a decision of Substantially Equivalent on November 14, 2003. 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. Aomori Olympus Co., Ltd. has at least 6 other 510(k) clearances on record.