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 C.R. Bard, Inc., Peca Labs and W.L. Gore & Associates, Inc..
188
Total
186
Cleared
114d
Avg days
1976
Since
Declining activity -
4 submissions in the last 2 years
vs 8 in the prior period
Review times increasing: avg
210d
recently vs 112d historically
FDA 510(k) Cleared Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Devices (Product Code DSY)
188 devices
Cleared
Apr 27, 2026
Fusion Bioline Vascular Graft
Maquet Cardiovascular, LLC
Cardiovascular
266d
Cleared
Oct 20, 2025
Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)
Vascular Flow Technologies Limited
Cardiovascular
90d
Cleared
Feb 27, 2025
Gelweave™ Vascular Prostheses
Vascutek, Ltd.
Cardiovascular
272d
Cleared
Nov 15, 2024
Gelsoft™ Plus Vascular Prostheses
Vascutek, Ltd.
Cardiovascular
210d
Cleared
Mar 28, 2024
Advanta VXT Vascular Graft, Flixene Vascular Graft
Atrium Medical Corporation
Cardiovascular
269d
Cleared
Mar 01, 2024
GORE® PROPATEN® Vascular Graft
W.L. Gore & Associates, Inc.
Cardiovascular
50d
Cleared
Jan 17, 2024
exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
Peca Labs, Inc.
Cardiovascular
51d
Cleared
Jan 09, 2024
GORE® PROPATEN® Vascular Graft
W.L. Gore & Associates, Inc.
Cardiovascular
160d
Cleared
Dec 19, 2023
GORE® ACUSEAL Vascular Graft
W.L. Gore & Associates, Inc.
Cardiovascular
46d
Cleared
Jun 23, 2023
GORE® ACUSEAL Vascular Graft
W.L. Gore & Associates, Inc.
Cardiovascular
30d
Cleared
Aug 15, 2022
HeRO Graft
Merit Medical Systems, Inc.
Cardiovascular
249d
Cleared
Aug 04, 2022
exGraft, exGraft Carbon
Peca Labs
Cardiovascular
59d
Cleared
May 25, 2021
HeRO Graft, HeRO Adapter
Merit Medical Systems, Inc.
Cardiovascular
155d
Cleared
Apr 06, 2021
Vascutek Gelsoft Plus ERS Vascular Graft
Vascutek, Ltd.
Cardiovascular
202d
Cleared
Dec 11, 2020
exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft
Peca Labs
Cardiovascular
105d
Cleared
Apr 22, 2019
exGraft, exGraft Carbon
Peca Labs
Cardiovascular
117d
Cleared
Aug 21, 2018
exGraft, exGraft Carbon ePTFE Vascular Grafts
Peca Labs
Cardiovascular
131d
Cleared
Nov 30, 2017
HeRO Graft
Merit Medical Systems, Inc.
Cardiovascular
90d
Cleared
Jan 17, 2012
EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL
Boston Scientific Corporation
Cardiovascular
90d
Cleared
Jan 06, 2006
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
Boston Scientific Corp
Cardiovascular
77d
Cleared
Jun 19, 1996
BARD GRAFT SIZER
C.R. Bard, Inc.
Cardiovascular
90d
Cleared
Dec 07, 1995
BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)
C.R. Bard, Inc.
Cardiovascular
91d
Cleared
Jun 02, 1994
BARD(R) EXPANDED PTFE VASCULAR GRAFT
C.R. Bard, Inc.
Cardiovascular
100d
Cleared
Jan 26, 1994
BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT
Baxter Healthcare Corp
Cardiovascular
184d
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 510(k) Review Time - DSY Product Code
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 →