Thoraflex Hybrid
FDA premarket approval P210006/S017 · decided 2026-04-20
Approval details
- PMA number
- P210006
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Thoraflex Hybrid
- Generic name
- Hybrid stent graft, thoracic aortic lesion treatment
- Applicant
- Vascutek, Ltd.
- Date received
- 2026-01-20
- Decision date
- 2026-04-20
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- QSK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Inchinnan
- Statement
- Approval for extension of shelf-life to 3-years
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Gelweave™ Vascular Prostheses (K241550) | Vascutek, Ltd. | 2025-02-27 |
| Gelsoft™ Plus Vascular Prostheses (K241070) | Vascutek, Ltd. | 2024-11-15 |
| Vascutek Gelsoft Plus ERS Vascular Graft (K202703) | Vascutek, Ltd. | 2021-04-06 |
| Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch (K200955) | Vascutek, Ltd. | 2020-07-08 |
| Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts (K162803) | Vascutek, Ltd. | 2017-07-14 |
| Gelweave Vascular Grafts (K162794) | Vascutek, Ltd. | 2017-06-30 |
| GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS (K093817) | Vascutek, Ltd. | 2010-01-07 |
| MAXIFLO, TAPERFLO (K092863) | Vascutek, Ltd. | 2009-10-08 |