510(k) K122138

ATRIUM FLIXENE IFG VASCULAR GRAFT by Atrium Medical Corp. — Product Code DSY

K122138 is an FDA 510(k) premarket notification submitted by Atrium Medical Corp. for the device "ATRIUM FLIXENE IFG VASCULAR GRAFT". The FDA issued a decision of Substantially Equivalent on August 17, 2012. The device falls under product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter), a Class II device regulated under 21 CFR 870.3450. Atrium Medical Corp. has at least 10 other 510(k) clearances on record.