510(k) K961438

BALLON DILATATION CATHETER by Boston Scientific Corp — Product Code KNQ

K961438 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "BALLON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on July 31, 1996. 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.