DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Class II
FDA product code DSY covers "Prosthesis, Vascular Graft, Of 6mm And Greater Diameter", a Class II medical device regulated under 21 CFR 870.3450. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DSY
- Device Class
- Class II
- Regulation Number
- 870.3450
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252445 | maquet cardiovascular | Fusion Bioline Vascular Graft | April 27, 2026 |
| K252277 | vascular flow technologies limited | Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) | October 20, 2025 |
| K241550 | vascutek | Gelweave Vascular Prostheses | February 27, 2025 |
| K241070 | vascutek | Gelsoft Plus Vascular Prostheses | November 15, 2024 |
| K231972 | atrium medical corporation | Advanta VXT Vascular Graft, Flixene Vascular Graft | March 28, 2024 |
| K240083 | w. l. gore and associates | GORE® PROPATEN® Vascular Graft | March 1, 2024 |
| K233783 | peca labs | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | January 17, 2024 |
| K232312 | w. l. gore and associates | GORE® PROPATEN® Vascular Graft | January 9, 2024 |
| K233551 | w. l. gore and associates | GORE® ACUSEAL Vascular Graft | December 19, 2023 |
| K231505 | w. l. gore and associates | GORE® ACUSEAL Vascular Graft | June 23, 2023 |
| K213845 | merit medical systems | HeRO Graft | August 15, 2022 |
| K221628 | peca labs | exGraft, exGraft Carbon | August 4, 2022 |
| K203724 | merit medical systems | HeRO Graft, HeRO Adapter | May 25, 2021 |
| K202703 | vascutek | Vascutek Gelsoft Plus ERS Vascular Graft | April 6, 2021 |
| K202471 | peca labs | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft | December 11, 2020 |
| K183613 | peca labs | exGraft, exGraft Carbon | April 22, 2019 |
| K180957 | peca labs | exGraft, exGraft Carbon ePTFE Vascular Grafts | August 21, 2018 |
| K172637 | merit medical systems | HeRO Graft | November 30, 2017 |
| K162803 | vascutek | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts | July 14, 2017 |
| K162794 | vascutek | Gelweave Vascular Grafts | June 30, 2017 |