FDA Product Code DSY: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
FDA product code DSY covers vascular graft prostheses with a diameter of 6mm or greater.
These synthetic conduits — typically made from Dacron (polyester) or ePTFE — replace or bypass diseased segments of the aorta, iliac, or femoral arteries in open vascular surgery. Large-diameter grafts are used in aortic aneurysm repair and aortoiliac occlusive disease.
DSY devices are Class II medical devices, regulated under 21 CFR 870.3450 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include W.L. Gore & Associates, Inc., Vascutek, Ltd. and Merit Medical Systems, Inc..
List of Prosthesis, Vascular Graft, Of 6mm And Greater Diameter devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Prosthesis, Vascular Graft, Of 6mm And Greater Diameter devices (product code DSY). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →