Intracranial Coil-Assist Stent
The Intracranial Coil-Assist Stent is a tubular implantable device placed in an artery in the brain to assist in the placement and retention of embolic coils for the treatment of wide-neck intracranial aneurysms. It is classified as FDA Class 3, the highest risk category requiring Premarket Approval (PMA), reflecting the significant risks associated with its use in intracranial vasculature. The product code is QCA with no assigned regulation number, reviewed by the Neurology panel. This device carries an implant flag, indicating it is surgically implanted in the body.
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Basic Information
- Product Code
- QCA
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- NE
- Submission Type
- 2
Device Characteristics
Definition
An intracranial coil-assist stent is a tubular device placed in an artery in the brain to assist in the placement and retention of embolic coils for the treatment of wide-neck intracranial aneurysms.
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.