Product code NUI

Device name

Ultrasound, Infusion, System

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.1200

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

For regional infusion of contrast materials into selected vessels in the neuro-vasculature. The device may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.

Source

FDA openFDA device classification dataset