DSYClass II

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

21 CFR 870.3450 / Cardiovascular

DSY is the FDA product code for Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, a class II device type, regulated under 21 CFR 870.3450. As of 2026-09-10, FDA records hold 188 510(k) clearances under this code, the most recent dated 2026-04-27, and 86 recalls.

Classification record

Product code: DSY
Device name: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Regulation: 21 CFR 870.3450
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 188
Ingested recalls: 87

Clearances, product code DSY

By decision year

188 clearances under product code DSY with a decision year between 1976 and 2026, 1991 the highest year at 12.

Show the numbers

510(k) clearances under FDA product code DSY by decision year
Year	Clearances
1976	4
1977	3
1979	1
1980	4
1981	6
1982	4
1983	6
1984	2
1985	1
1986	7
1987	1
1988	7
1989	4
1990	6
1991	12
1992	2
1993	3
1994	5
1995	4
1996	7
1997	9
1998	4
1999	9
2000	3
2001	7
2002	5
2003	3
2004	3
2005	5
2006	6
2007	1
2008	1
2009	5
2010	4
2011	1
2012	4
2013	5
2014	2
2015	1
2016	1
2017	3
2018	1
2019	1
2020	1
2021	2
2022	2
2023	2
2024	5
2025	2
2026	1

Applicants with the most clearances

Product code DSY

Applicants holding the most 510(k) clearances under product code DSY
Applicant	Clearances
W. L. Gore & Associates, Inc.	24
Vascutek, Ltd.	22
Atrium Medical Corporation	18
Intervascular, Inc.	16
Meadox Medicals, Div. Boston Scientific Corp.	15
Impra, Inc.	8
C.R. Bard Inc	7
Peca Labs, Inc.	5
Shiley, Inc.	5
Medtronic, Inc.	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order