510(k) K091495

SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A by Olympus Medical Systems Corporation — Product Code LQR

K091495 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corporation for the device "SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A". The FDA issued a decision of Substantially Equivalent on September 3, 2009. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Olympus Medical Systems Corporation has at least 10 other 510(k) clearances on record.