510(k) K231972

Advanta VXT Vascular Graft, Flixene Vascular Graft by Atrium Medical Corporation — Product Code DSY

K231972 is an FDA 510(k) premarket notification submitted by Atrium Medical Corporation for the device "Advanta VXT Vascular Graft, Flixene Vascular Graft". The FDA issued a decision of Substantially Equivalent on March 28, 2024. 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 Corporation has at least 5 other 510(k) clearances on record.