510(k) K102596

ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT by Atrium Medical Corp. — Product Code DSY

K102596 is an FDA 510(k) premarket notification submitted by Atrium Medical Corp. for the device "ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT". The FDA issued a decision of Substantially Equivalent on October 5, 2010. 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.