510(k) K131778

FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT by Maquet Cardiovascular, LLC — Product Code DSY

K131778 is an FDA 510(k) premarket notification submitted by Maquet Cardiovascular, LLC for the device "FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT". The FDA issued a decision of Substantially Equivalent on November 14, 2013. 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. Maquet Cardiovascular, LLC has at least 10 other 510(k) clearances on record.