Thoraflex™ Hybrid

FDA UDI

Class III (US FDA UDI)

by Vascutek Ltd

Identity

Trade Name: Thoraflex™ Hybrid FDA UDI
Generic Name: Synthetic vascular graft FDA UDI
Device Name: Thoraflex Hybrid Plexus FDA UDI
Model / Reference: THP2224X100B FDA UDI
Description: Thoraflex Hybrid Plexus FDA UDI

Identifiers

Catalog Number: THP2224X100B FDA UDI
Primary DI / UDI-DI: 05037881031712 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Stent Diameter — 24 Millimeter FDA UDI
Stent Length — 100 Millimeter FDA UDI

Category: Synthetic vascular graft

Thoraflex Hybrid Plexus is a cutting-edge, hybrid stent graft designed for thoracic aortic lesion treatment. This implantable artificial substitute replaces or bypasses diseased or injured vessels in the aorta, iliac arteries, femoral or popliteal arteries, typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics without incorporating a metallic mesh. The device is MR Conditional and undergoes comprehensive testing to ensure its safety for patients.

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:

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 212662a6-663c-4a22-88af-04a6e058223c 37 fields · synced Jun 27, 2026