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 Atrium Medical Corp..