OUT — Intracranial Aneurysm Flow Diverter Class III

FDA Device Classification

FDA product code OUT covers "Intracranial Aneurysm Flow Diverter", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.

Classification Details

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

Definition

Treatment of wide-necked and larger or giant intracranial aneurysms.