510(k) K061787

MAXFORCE TTS SINGLE-USE BALLOON DILATOR by Boston Scientific Corp — Product Code KNQ

K061787 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "MAXFORCE TTS SINGLE-USE BALLOON DILATOR". The FDA issued a decision of Substantially Equivalent on September 21, 2006. 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.