DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Class II
FDA Device Classification
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 |
|---|
| 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 |
| K153523 | maquet cardiovascular | FUSION Vascular Graft | February 16, 2016 |