QSK · Hybrid Stent Graft, Thoracic Aortic Lesion Treatment
· Class 3
Overview
| Product Code | QSK |
|---|---|
| Device Name | Hybrid Stent Graft, Thoracic Aortic Lesion Treatment |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
Repair or replacement of damaged or diseased vessel of the aortic arch and descending thoracic aorta, with or without involvement of ascending aorta, using vascular grafts and/or stent grafts placed during open surgical repair.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P210006 | Thoraflex Hybrid | Vascutek, Ltd. | Apr 19, 2022 | APPR |
Top Applicants
- Vascutek, Ltd. — 1 clearance
