510(k) K030769

ULTRAFLEX PRECISION COLONIC STENT by Boston Scientific Corp — Product Code MQR

K030769 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "ULTRAFLEX PRECISION COLONIC STENT". The FDA issued a decision of Substantially Equivalent on July 14, 2003. The device falls under product code MQR (Stent, Colonic, Metallic, Expandable), a Class II device regulated under 21 CFR 878.3610. Boston Scientific Corp has at least 10 other 510(k) clearances on record.