Aortic stent grafts
CustomSeal Kit
A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.
CustomSeal Kit 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 |
|---|---|---|---|
| TV-CS14-G | Total Volume 14 mL | MR Conditional | Available |
FDA clearances
- PMA P120006 August 2013
Procedures that use aortic stent grafts
Frequently asked questions
What is CustomSeal Kit used for?
A non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.
Who makes CustomSeal Kit?
CustomSeal Kit is made by Endologix LLC. It is listed under aortic stent grafts (evar/tevar) in our device library.
What sizes does CustomSeal Kit come in?
Sizes listed for CustomSeal Kit: Total Volume: 14 mL. Confirm availability with the manufacturer's instructions for use.
Is CustomSeal Kit MRI safe?
The FDA device database lists CustomSeal Kit as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is CustomSeal Kit FDA cleared?
CustomSeal Kit is covered by FDA submission P120006.
How do I contact a Endologix LLC sales representative?
Endologix LLC has not listed representatives on LA Vascular yet. Visit the Endologix LLC 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.