NJE — Intracranial Neurovascular Stent Class f

FDA Device Classification

FDA product code NJE covers "Intracranial Neurovascular Stent", a Class f medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.

Classification Details

Product Code
NJE
Device Class
Class f
Regulation Number
Submission Type
Review Panel
NE
Medical Specialty
Unknown
Implant
Yes

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.