Intracranial Aneurysm Flow Diverter
The Intracranial Aneurysm Flow Diverter (product code OUT) is an implantable neurovascular device used for the treatment of wide-necked and larger or giant intracranial aneurysms. It is a stent-like device deployed within the parent artery to divert blood flow away from the aneurysm sac, promoting thrombosis and aneurysm occlusion. As an FDA Class 3 device without an assigned regulation number, it requires Premarket Approval (PMA) to demonstrate safety and effectiveness, and is reviewed by the Neurology panel. The device is flagged as an implant and is not life-sustaining.
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Basic Information
- Product Code
- OUT
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- NE
- Submission Type
- 2
Device Characteristics
Definition
Treatment of wide-necked and larger or giant intracranial aneurysms.
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.