510(k) K954290

WALLSTENT ENTERAL ENDOPROTHESIS by Boston Scientific Scimed, Inc. — Product Code MQR

K954290 is an FDA 510(k) premarket notification submitted by Boston Scientific Scimed, Inc. for the device "WALLSTENT ENTERAL ENDOPROTHESIS". The FDA issued a decision of Substantially Equivalent on July 10, 1996. The device falls under product code MQR (Stent, Colonic, Metallic, Expandable), a Class II device regulated under 21 CFR 878.3610. Boston Scientific Scimed, Inc. has at least 10 other 510(k) clearances on record.