Aortic stent grafts
Zenith
by William a. Cook Australia Pty. Ltd.
An implantable artificial substitute for a blood vessel intended to replace, bypass or shunt a portion of peripheral vasculature (excludes coronary and cerebral arteries) due to a disease, injury, or for haemodialysis access. It is made of synthetic polymer materials [e.g., woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics]; it does not contain any pharmaceuticals and does not incorporate a metallic mesh (i.e., it is not a stent-graft).
Zenith models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| G32500 | β | MR Conditional | Available |
| G32501 | β | MR Conditional | Available |
| G32502 | β | MR Conditional | Available |
| G32503 | β | MR Conditional | Available |
| G32504 | β | MR Conditional | Available |
| G32505 | β | MR Conditional | Available |
| G32506 | β | MR Conditional | Available |
| G32507 | β | MR Conditional | Available |
| G32508 | β | MR Conditional | Available |
| G32509 | β | MR Conditional | Available |
| G32510 | β | MR Conditional | Available |
| G32511 | β | MR Conditional | Available |
| G32512 | β | MR Conditional | Available |
| G32513 | β | MR Conditional | Available |
| G32514 | β | MR Conditional | Available |
| G32515 | β | MR Conditional | Available |
| G32516 | β | MR Conditional | Available |
| G32517 | β | MR Conditional | Available |
| G32518 | β | MR Conditional | Available |
| G32519 | β | MR Conditional | Available |
| G32520 | β | MR Conditional | Available |
| G32521 | β | MR Conditional | Available |
| G32522 | β | MR Conditional | Available |
| G32523 | β | MR Conditional | Available |
| G32524 | β | MR Conditional | Available |
| G32525 | β | MR Conditional | Available |
| G32526 | β | MR Conditional | Available |
| G32527 | β | MR Conditional | Available |
| G32528 | β | MR Conditional | Available |
| G32529 | β | MR Conditional | Available |
| G32530 | β | MR Conditional | Available |
| G32531 | β | MR Conditional | Available |
| G32532 | β | MR Conditional | Available |
| G32533 | β | MR Conditional | Available |
| G32534 | β | MR Conditional | Available |
| G32535 | β | MR Conditional | Available |
| G32536 | β | MR Conditional | Available |
| G32537 | β | MR Conditional | Available |
| G32538 | β | MR Conditional | Available |
| G32539 | β | MR Conditional | Available |
| G32540 | β | MR Conditional | Available |
| G32541 | β | MR Conditional | Available |
| G32542 | β | MR Conditional | Available |
| G32543 | β | MR Conditional | Available |
| G32544 | β | MR Conditional | Available |
| G32545 | β | MR Conditional | Available |
| G32546 | β | MR Conditional | Available |
| G32547 | β | MR Conditional | Available |
| G32548 | β | MR Conditional | Available |
| G32549 | β | MR Conditional | Available |
| G32550 | β | MR Conditional | Available |
| G32551 | β | MR Conditional | Available |
| G32552 | β | MR Conditional | Available |
| G32553 | β | MR Conditional | Available |
| G32554 | β | MR Conditional | Available |
| G32555 | β | MR Conditional | Available |
| G32556 | β | MR Conditional | Available |
| G32557 | β | MR Conditional | Available |
| G32558 | β | MR Conditional | Available |
| G32559 | β | MR Conditional | Available |
| G32560 | β | MR Conditional | Available |
| G32561 | β | MR Conditional | Available |
| G32562 | β | MR Conditional | Available |
| G32563 | β | MR Conditional | Available |
| G32564 | β | MR Conditional | Available |
| G32565 | β | MR Conditional | Available |
| G32566 | β | MR Conditional | Available |
| G32567 | β | MR Conditional | Available |
| G32568 | β | MR Conditional | Available |
| G32569 | β | MR Conditional | Available |
| G32570 | β | MR Conditional | Available |
| G32571 | β | MR Conditional | Available |
| G32572 | β | MR Conditional | Available |
| G32573 | β | MR Conditional | Available |
| G32574 | β | MR Conditional | Available |
| G32575 | β | MR Conditional | Available |
| G32576 | β | MR Conditional | Available |
| G32577 | β | MR Conditional | Available |
| G32578 | β | MR Conditional | Available |
| G32579 | β | MR Conditional | Available |
| G32580 | β | MR Conditional | Available |
| G32581 | β | MR Conditional | Available |
| G32582 | β | MR Conditional | Available |
| G32583 | β | MR Conditional | Available |
| G32584 | β | MR Conditional | Available |
| G32585 | β | MR Conditional | Available |
| G32586 | β | MR Conditional | Available |
| G32587 | β | MR Conditional | Available |
| G32588 | β | MR Conditional | Available |
| G32589 | β | MR Conditional | Available |
| G32590 | β | MR Conditional | Available |
| G32591 | β | MR Conditional | Available |
| G32592 | β | MR Conditional | Available |
FDA clearances
- PMA P020018 December 2023
Procedures that use aortic stent grafts
Frequently asked questions
What is Zenith used for?
An implantable artificial substitute for a blood vessel intended to replace, bypass or shunt a portion of peripheral vasculature (excludes coronary and cerebral arteries) due to a disease, injury, or for haemodialysis access. It is made of synthetic polymer materials [e.g., woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics]; it does not contain any pharmaceuticals and does not incorporate a metallic mesh (i.e., it is not a stent-graft).
Who makes Zenith?
Zenith is made by William a. Cook Australia Pty. Ltd.. It is listed under aortic stent grafts (evar/tevar) in our device library.
What sizes does Zenith come in?
The FDA device database does not list sizes for Zenith. Check the instructions for use or ask a William a. Cook Australia Pty. Ltd. representative.
Is Zenith MRI safe?
The FDA device database lists Zenith as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Zenith FDA cleared?
Zenith is covered by FDA submission P020018.
How do I contact a William a. Cook Australia Pty. Ltd. sales representative?
William a. Cook Australia Pty. Ltd. has not listed representatives on LA Vascular yet. Visit the William a. Cook Australia Pty. Ltd. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.