510(k) K952656

XXL BALLOON DILATATION CATHETER by Boston Scientific Corp — Product Code KNQ

K952656 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "XXL BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on July 19, 1995. The device falls under product code KNQ (Dilator, Esophageal), a Class II device regulated under 21 CFR 876.5365. Boston Scientific Corp has at least 10 other 510(k) clearances on record.