Identity
- Trade Name
- Thoraflex™ Hybrid FDA UDI
- Generic Name
- Synthetic vascular graft FDA UDI
- Device Name
- Thoraflex Hybrid Plexus 4 Hybrid Stent Device FDA UDI
- Model / Reference
- THP3040X150A FDA UDI
- Description
- Thoraflex Hybrid Plexus 4 Hybrid Stent Device FDA UDI
Identifiers
- Catalog Number
- THP3040X150A FDA UDI
- Primary DI / UDI-DI
- 05037881026862 FDA UDI
- PMA Number
- P210006 FDA UDI
- FDA Product Code
- QSK FDA UDI
- GMDN Term
- Synthetic vascular graft FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 242150 Millimeter FDA UDILumen/Inner Diameter — 30 Millimeter FDA UDI
Category: Synthetic vascular graft
Thoraflex Hybrid is a highly effective hybrid stent graft designed for thoracic aortic lesion treatment. This advanced device combines the benefits of woven or knitted polyethylene terephthalate (Dacron) and polytetrafluoroethylene (PTFE) fabrics, making it an ideal choice for patients requiring a durable yet flexible replacement vessel.
Similar devices
Also classified as Synthetic vascular graft.
- GORE PROPATEN Vascular Graft Pediatric Shunt — W. L. GORE & ASSOCIATES, INC · Class II
- COOK — William Cook Europe ApS · Class III
- Zenith — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class III
- ADVANTA SLIDER GDS — Atrium Medical Corp. · Class II
- IMPRA® ePTFE Vascular Grafts — Bard Peripheral Vascular · Class II
- Zenith — WILLIAM A. COOK AUSTRALIA PTY. LTD. · Class III
- Hemashield — Intervascular, Inc. · Class II
- Zenith Alpha — William Cook Europe ApS · Class III
Cleared under the same submission
P210006 also covers:
- Thoraflex™ Hybrid — VASCUTEK LTD
- Thoraflex™ Hybrid — VASCUTEK LTD
- Thoraflex™ Hybrid — VASCUTEK LTD
- Thoraflex™ Hybrid — VASCUTEK LTD
- Thoraflex™ Hybrid — VASCUTEK LTD
- Thoraflex™ Hybrid — VASCUTEK LTD
- Thoraflex™ Hybrid — VASCUTEK LTD
- Thoraflex™ Hybrid — VASCUTEK LTD
- Thoraflex™ Hybrid — VASCUTEK LTD
- Thoraflex™ Hybrid — VASCUTEK LTD
- Thoraflex™ Hybrid — VASCUTEK LTD
- Thoraflex™ Hybrid — VASCUTEK LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Vascutek Ltd
Sources (1)
- FDA UDI e41ecd81-0f7c-4f8d-98aa-d5623a55c340 37 fields · synced Jul 17, 2026