Aortic stent grafts
Zenith TX2 Pro-Form
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 TX2 Pro-Form 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 |
|---|---|---|---|
| G24139 | — | MR Conditional | Available |
| G24140 | — | MR Conditional | Available |
| G53418 | — | MR Conditional | Available |
| G53419 | — | MR Conditional | Available |
| G53420 | — | MR Conditional | Available |
| G53421 | — | MR Conditional | Available |
| G53422 | — | MR Conditional | Available |
| G53423 | — | MR Conditional | Available |
| G53424 | — | MR Conditional | Available |
| G53425 | — | MR Conditional | Available |
| G53426 | — | MR Conditional | Available |
| G53427 | — | MR Conditional | Available |
| G53428 | — | MR Conditional | Available |
| G53429 | — | MR Conditional | Available |
| G53430 | — | MR Conditional | Available |
| G53431 | — | MR Conditional | Available |
| G53432 | — | MR Conditional | Available |
| G53433 | — | MR Conditional | Available |
| G53434 | — | MR Conditional | Available |
| G53435 | — | MR Conditional | Available |
| G53436 | — | MR Conditional | Available |
| G53437 | — | MR Conditional | Available |
| G53438 | — | MR Conditional | Available |
| G53439 | — | MR Conditional | Available |
| G53440 | — | MR Conditional | Available |
| G53441 | — | MR Conditional | Available |
| G53442 | — | MR Conditional | Available |
| G53443 | — | MR Conditional | Available |
| G53444 | — | MR Conditional | Available |
| G53445 | — | MR Conditional | Available |
| G53446 | — | MR Conditional | Available |
| G53447 | — | MR Conditional | Available |
| G53448 | — | MR Conditional | Available |
| G53449 | — | MR Conditional | Available |
| G53450 | — | MR Conditional | Available |
| G53451 | — | MR Conditional | Available |
| G53452 | — | MR Conditional | Available |
| G53453 | — | MR Conditional | Available |
| G53454 | — | MR Conditional | Available |
| G53455 | — | MR Conditional | Available |
| G53456 | — | MR Conditional | Available |
| G53457 | — | MR Conditional | Available |
| G53458 | — | MR Conditional | Available |
| G53459 | — | MR Conditional | Available |
| G53460 | — | MR Conditional | Available |
| G53461 | — | MR Conditional | Available |
| G53462 | — | MR Conditional | Available |
| G53463 | — | MR Conditional | Available |
| G53464 | — | MR Conditional | Available |
| G53465 | — | MR Conditional | Available |
| G53466 | — | MR Conditional | Available |
| G53467 | — | MR Conditional | Available |
| G53468 | — | MR Conditional | Available |
| G53469 | — | MR Conditional | Available |
| G53471 | — | MR Conditional | Available |
| G53472 | — | MR Conditional | Available |
| G53473 | — | MR Conditional | Available |
| G53474 | — | MR Conditional | Available |
| G53476 | — | MR Conditional | Available |
| G53477 | — | MR Conditional | Available |
| G53478 | — | MR Conditional | Available |
| G53479 | — | MR Conditional | Available |
| G53480 | — | MR Conditional | Available |
| G53481 | — | MR Conditional | Available |
| G53482 | — | MR Conditional | Available |
| G53483 | — | MR Conditional | Available |
| G53484 | — | MR Conditional | Available |
| G53485 | — | MR Conditional | Available |
| G53486 | — | MR Conditional | Available |
| G53487 | — | MR Conditional | Available |
FDA clearances
- PMA P070016 May 2008
Procedures that use aortic stent grafts
Frequently asked questions
What is Zenith TX2 Pro-Form 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 TX2 Pro-Form?
Zenith TX2 Pro-Form is made by William Cook Europe ApS. It is listed under aortic stent grafts (evar/tevar) in our device library.
What sizes does Zenith TX2 Pro-Form come in?
The FDA device database does not list sizes for Zenith TX2 Pro-Form. Check the instructions for use or ask a William Cook Europe ApS representative.
Is Zenith TX2 Pro-Form MRI safe?
The FDA device database lists Zenith TX2 Pro-Form as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is Zenith TX2 Pro-Form FDA cleared?
Zenith TX2 Pro-Form is covered by FDA submission P070016.
How do I contact a William Cook Europe ApS sales representative?
William Cook Europe ApS has not listed representatives on LA Vascular yet. Visit the William Cook Europe ApS 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.