510(k) K123214

ENCORE 26 ADVANTAGE KIT by Boston Scientific Corp — Product Code MAV

K123214 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "ENCORE 26 ADVANTAGE KIT". The FDA issued a decision of Substantially Equivalent on November 13, 2012. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Boston Scientific Corp has at least 10 other 510(k) clearances on record.