DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Cardiovascular · 21 CFR 870.3450 · Class 2
Overview
| Product Code | DSY |
|---|---|
| Device Name | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Regulation | 21 CFR 870.3450 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
Recent Cleared Devices (20 of 188)
Showing 20 most recent of 188 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252277 | Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645) | Vascular Flow Technologies Limited | Oct 20, 2025 | SESE |
| K241550 | Gelweave Vascular Prostheses | Vascutek, Ltd. | Feb 27, 2025 | SESE |
| K241070 | Gelsoft Plus Vascular Prostheses | Vascutek, Ltd. | Nov 15, 2024 | SESE |
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular Graft | Atrium Medical Corporation | Mar 28, 2024 | SESE |
| K240083 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | Mar 1, 2024 | SESE |
| K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | Peca Labs, Inc. | Jan 17, 2024 | SESE |
| K232312 | GORE® PROPATEN® Vascular Graft | W. L. Gore & Associates, Inc. | Jan 9, 2024 | SESE |
| K233551 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | Dec 19, 2023 | SESE |
| K231505 | GORE® ACUSEAL Vascular Graft | W. L. Gore & Associates, Inc. | Jun 23, 2023 | SESE |
| K213845 | HeRO Graft | Merit Medical Systems, Inc. | Aug 15, 2022 | SESE |
| K221628 | exGraft, exGraft Carbon | Peca Labs | Aug 4, 2022 | SESE |
| K203724 | HeRO Graft, HeRO Adapter | Merit Medical Systems, Inc. | May 25, 2021 | SESE |
| K202703 | Vascutek Gelsoft Plus ERS Vascular Graft | Vascutek, Ltd. | Apr 6, 2021 | SESE |
| K202471 | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft | Peca Labs | Dec 11, 2020 | SESE |
| K183613 | exGraft, exGraft Carbon | Peca Labs | Apr 22, 2019 | SESE |
| K180957 | exGraft, exGraft Carbon ePTFE Vascular Grafts | Peca Labs | Aug 21, 2018 | SESE |
| K172637 | HeRO Graft | Merit Medical Systems, Inc. | Nov 30, 2017 | SESE |
| K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts | Vascutek, Ltd. | Jul 14, 2017 | SESE |
| K162794 | Gelweave Vascular Grafts | Vascutek, Ltd. | Jun 30, 2017 | SESE |
| K153523 | FUSION Vascular Graft | Maquet Cardiovascular, LLC | Feb 16, 2016 | SESE |
Top Applicants
- W. L. Gore & Associates, Inc. — 23 clearances
- Vascutek, Ltd. — 22 clearances
- Atrium Medical Corp. — 16 clearances
- Meadox Medicals, Div. Boston Scientific Corp. — 15 clearances
- Intervascular, Inc. — 14 clearances
