Identity
- Trade Name
- Thoraflex Hybrid FDA PMA
- Generic Name
- Hybrid stent graft, thoracic aortic lesion treatment FDA PMA
Identifiers
- PMA Number
- P210006 FDA PMA
- FDA Product Code
- QSK FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Thoraflex Hybrid is a hybrid stent graft designed for the treatment of thoracic aortic lesions. It is indicated for the open surgical repair or replacement of damaged or diseased vessels of the aortic arch and descending aorta, including cases involving the ascending aorta such as aneurysms and dissections.
This device is manufactured by Vascutek Ltd and has received FDA PMA approval under reference P210006. It is intended for use by medical professionals in a surgical setting to address complex vascular conditions of the thoracic aorta.
Frequently asked questions
What is the primary use of the Thoraflex Hybrid?
The Thoraflex Hybrid is used for the open surgical repair or replacement of damaged or diseased vessels in the aortic arch and descending aorta, specifically in patients with aneurysms or dissections.
Who manufactures the Thoraflex Hybrid?
The Thoraflex Hybrid is manufactured by Vascutek Ltd, based in Inchinnan, and is authorized for use under FDA PMA approval P210006.
Is the Thoraflex Hybrid suitable for ascending aorta involvement?
Yes, the device is indicated for the repair or replacement of vessels in the aortic arch and descending aorta, with or without involvement of the ascending aorta.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P210006 | Class III | Active |
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Manufacturer
- Manufacturer
- Vascutek Ltd
- FDA Applicant
- Vascutek, Ltd.
Sources (1)
- FDA PMA P210006 24 fields · synced Sep 18, 2026