510(k) K133750

OCCLUDER OCCLUSION BALLOON CATHETER by Boston Scientific Corporation — Product Code EYB

K133750 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "OCCLUDER OCCLUSION BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on January 8, 2014. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.