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..
FDA 510(k) Cleared Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Devices (Product Code DSY)
About Product Code DSY - Regulatory Context
510(k) Submission Activity
188 total 510(k) submissions under product code DSY since 1976, with 186 receiving FDA clearance (average review time: 114 days).
Submission volume has declined in recent years - 4 submissions in the last 24 months compared to 8 in the prior period.
FDA Review Time
Recent submissions under DSY have taken an average of 210 days to reach a decision - up from 112 days historically. Manufacturers should account for longer review timelines in current project planning.
DSY devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →