Vascutek, Ltd.
FDA 510(k) & PMA Approved Devices — 7 products
Total Devices7
Categories3
Latest FDA decision2026-06-24
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P210006 | Hybrid stent graft, thoracic aortic lesion treatment | QSK | 2026-06-24 | View |
| 510(k) | K241550 | Gelweave™ Vascular Prostheses | DSY | 2025-02-27 | View |
| 510(k) | K241070 | Gelsoft™ Plus Vascular Prostheses | DSY | 2024-11-15 | View |
| 510(k) | K202703 | Vascutek Gelsoft Plus ERS Vascular Graft | DSY | 2021-04-06 | View |
| 510(k) | K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | DXZ | 2020-07-08 | View |
| 510(k) | K162803 | Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts | DSY | 2017-07-14 | View |
| 510(k) | K162794 | Gelweave Vascular Grafts | DSY | 2017-06-30 | View |
No matching devices.