510(k) K122924

CRE FIXED WIRE BALLON DILATION CATHETER by Boston Scientific Corp — Product Code KNQ

K122924 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "CRE FIXED WIRE BALLON DILATION CATHETER". The FDA issued a decision of Substantially Equivalent on October 24, 2012. 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.