DSY
- Product code
- DSY
- Device name
- Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.3450
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 9
- Summaries archived here
- 9 (direct download)
- 510(k) clearances (all years, FDA)
- 188 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (9)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252445 | 2026-04-27 | Maquet Cardiovascular, LLC | Fusion Bioline Vascular Graft | |
| K252277 | 2025-10-20 | Vascular Flow Technologies Limited | Spiral Laminar Flow Vascular Arteriovenous Graft (… | |
| K241550 | 2025-02-27 | Vascutek, Ltd. | Gelweave Vascular Prostheses | |
| K241070 | 2024-11-15 | Vascutek, Ltd. | Gelsoft Plus Vascular Prostheses | |
| K231972 | 2024-03-28 | Atrium Medical Corporation | Advanta VXT Vascular Graft, Flixene Vascular Graft | |
| K240083 | 2024-03-01 | W. L. Gore & Associates, Inc. | GORE® PROPATEN® Vascular Graft | |
| K233783 | 2024-01-17 | Peca Labs, Inc. | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE … | |
| K232312 | 2024-01-09 | W. L. Gore & Associates, Inc. | GORE® PROPATEN® Vascular Graft | |
| K233551 | 2023-12-19 | W. L. Gore & Associates, Inc. | GORE® ACUSEAL Vascular Graft |
Official FDA classification page: DSY
Classification and pathway per current FDA publications. Data from openFDA (CC0).