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Zenith Alpha

FDA UDI

Class III (US FDA UDI)

by William Cook Europe ApS

Identity

Trade Name
Zenith Alpha FDA UDI
Generic Name
Synthetic vascular graft FDA UDI
Device Name
Zenith Alpha, Thoracic Endovascular Graft, Distal Extension FDA UDI
Model / Reference
G35505 FDA UDI
Description
Zenith Alpha, Thoracic Endovascular Graft, Distal Extension FDA UDI

Identifiers

Catalog Number
ZTA-DE-20-148-W FDA UDI
Primary DI / UDI-DI
10827002355054 FDA UDI
PMA Number
P140016 FDA UDI
FDA Product Code
MIH FDA UDI
GMDN Term
Synthetic vascular graft FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

The Zenith Alpha is a synthetic vascular graft designed for thoracic endovascular procedures. It's an implantable, non-stent-graft solution that replaces or bypasses diseased arteries, typically the aorta, iliac, femoral, or popliteal artery. The device features woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and does not incorporate metallic meshes. Its MR Conditional safety profile means it can be used on the brain.

Cleared under the same submission

P140016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
William Cook Europe ApS

Sources (1)

  • FDA UDI 88521d58-d67f-42f7-b9c7-0e0f9fe5c20e 38 fields · synced Aug 3, 2026