Coils
MReye
A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
MReye 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 |
|---|---|---|---|
| G11324 | — | MR Conditional | Available |
| G11583 | — | MR Conditional | Available |
| G11584 | — | MR Conditional | Available |
| G11587 | — | MR Conditional | Available |
| G11588 | — | MR Conditional | Available |
| G12841 | — | MR Conditional | Available |
FDA clearances
- 510(k) K150931 December 2015
Procedures that use coils
Frequently asked questions
What is MReye used for?
A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
Who makes MReye?
MReye is made by Cook Incorporated. It is listed under embolization coils, biopsy needles and systems in our device library.
What sizes does MReye come in?
The FDA device database does not list sizes for MReye. Check the instructions for use or ask a Cook Incorporated representative.
Is MReye MRI safe?
The FDA device database lists MReye as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is MReye FDA cleared?
MReye is covered by FDA submission K150931.
How do I contact a Cook Incorporated sales representative?
Cook Incorporated has not listed representatives on LA Vascular yet. Visit the Cook Incorporated 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.