QCA — Intracranial Coil-Assist Stent Class III

FDA Device Classification

FDA product code QCA covers "Intracranial Coil-Assist Stent", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.

Classification Details

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

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.