510(k) K231505

GORE® ACUSEAL Vascular Graft by W. L. Gore & Associates, Inc. — Product Code DSY

K231505 is an FDA 510(k) premarket notification submitted by W. L. Gore & Associates, Inc. for the device "GORE® ACUSEAL Vascular Graft". The FDA issued a decision of Substantially Equivalent on June 23, 2023. 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. W. L. Gore & Associates, Inc. has at least 10 other 510(k) clearances on record.