Intracranial Neurovascular Stent
The Intracranial Neurovascular Stent is a tubular implantable device placed in the blood vessels of the intracranial cavity to treat vascular abnormalities such as cerebral aneurysms, distinguishing itself from other stents by its specific indication for intracranial use. This device has a device class of "f" (not classifiable under a standard classification) and is subject to FDA's premarket approval or de novo process (submission type 6), under product code NJE in the Neurology review panel (no regulation number assigned). The device is flagged as an implant but is not life-sustaining.
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Basic Information
- Product Code
- NJE
- Medical Specialty
- Unknown
- Review Panel
- NE
- Submission Type
- 6
Device Characteristics
Definition
An intracranial neurovascular stent is a tubular device placed in the blood vessel of the intracranial cavity to treat a vascular abnormality. It differs from other stents in that it is intended for intracranial use.
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.