Product code QCA

Device name

Intracranial Coil-Assist Stent

Medical specialty

Unknown

Device class

3

Review panel

NE

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset