510(k) K252445

Fusion Bioline Vascular Graft by Maquet Cardiovascular, LLC — Product Code DSY

K252445 is an FDA 510(k) premarket notification submitted by Maquet Cardiovascular, LLC for the device "Fusion Bioline Vascular Graft". The FDA issued a decision of Substantially Equivalent on April 27, 2026. 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.