Product code SDG

Device name

Brain Intraparenchymal Infusion Cannula

Medical specialty

Neurology

Device class

2

Regulation number

882.4110

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

A brain intraparenchymal infusion cannula is a non-powered, hollow tube-like device with a rigid component for stereotaxic-aided temporary placement in brain parenchyma tissue to deliver a therapy.

Source

FDA openFDA device classification dataset