510(k) K081052

OCCLUSION BALLOON CATHETER, MODEL VENOS by Oscor, Inc. — Product Code DYG

K081052 is an FDA 510(k) premarket notification submitted by Oscor, Inc. for the device "OCCLUSION BALLOON CATHETER, MODEL VENOS". The FDA issued a decision of Substantially Equivalent on June 18, 2008. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Oscor, Inc. has at least 10 other 510(k) clearances on record.