FDA product code DSY: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
DSY is the FDA product code for prosthesis, vascular graft, of 6mm and greater diameter. It is a Class II device, regulated under 21 CFR 870.3450 and reviewed by the Cardiovascular panel. FDA has cleared 188 510(k) submissions under DSY, 12 in the last five years, from 53 different applicants. The average 510(k) review took 114 days (median 88); 198 days on average over the last three years. 1 PMA application cites this product code. FDA has posted 87 recalls for DSY devices, 59 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Device class | Class II |
| Regulation | 21 CFR 870.3450 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for DSY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 214 |
| 2018 | 1 | 131 |
| 2019 | 1 | 117 |
| 2020 | 1 | 105 |
| 2021 | 2 | 178 |
| 2022 | 2 | 154 |
| 2023 | 2 | 38 |
| 2024 | 5 | 148 |
| 2025 | 2 | 181 |
| 2026 | 1 | 266 |
Compare with all 510(k) review times · Search every DSY clearance
Top DSY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| W. L. Gore & Associates, Inc. | 23 | 2024-03-01 |
| Vascutek, Ltd. | 22 | 2025-02-27 |
| Atrium Medical Corp. | 16 | 2012-08-17 |
| Meadox Medicals, Div. Boston Scientific Corp. | 15 | 1997-03-17 |
| Intervascular, Inc. | 14 | 2001-01-08 |
48 more applicants have DSY clearances. See the full list in Caduvo.
Most recent DSY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252445 | Maquet Cardiovascular, LLC | Fusion Bioline Vascular Graft | 2026-04-27 | 266 |
| K252277 | Vascular Flow Technologies Limited | Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) | 2025-10-20 | 90 |
| K241550 | Vascutek, Ltd. | Gelweave Vascular Prostheses | 2025-02-27 | 272 |
| K241070 | Vascutek, Ltd. | Gelsoft Plus Vascular Prostheses | 2024-11-15 | 210 |
| K231972 | Atrium Medical Corporation | Advanta VXT Vascular Graft, Flixene Vascular Graft | 2024-03-28 | 269 |
Recalls for DSY devices
87 product recalls in 21 recall events; 59 initiated in the last five years and 60 still open. Most recent: 2026-08-12.
| Year | Recalls |
|---|---|
| 2021 | 4 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 54 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code DSY?
DSY is the FDA product code for prosthesis, vascular graft, of 6mm and greater diameter. It is a Class II device, regulated under 21 CFR 870.3450 and reviewed by the Cardiovascular panel.
What device class is DSY?
Class II, regulation 21 CFR 870.3450. Typical premarket route: 510(k).
How long does a 510(k) take for product code DSY?
Across 188 cleared submissions the average was 114 days from receipt to decision (median 88).
Which companies have the most DSY clearances?
W. L. Gore & Associates, Inc. (23); Vascutek, Ltd. (22); Atrium Medical Corp. (16); Meadox Medicals, Div. Boston Scientific Corp. (15); Intervascular, Inc. (14).
Have DSY devices been recalled?
Yes: 87 product recalls across 21 recall events; the most recent began 2026-08-12.
Next steps
- Run an FDA pathway report with predicate devices for product code DSY
- Run a recall and safety report across every DSY manufacturer
- Watch product code DSY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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