510(k) K974788

CRE(TM) BALLOON DILATATION CATHETER by Boston Scientific Corp — Product Code KNQ

K974788 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "CRE(TM) BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on March 20, 1998. 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.