NUI

Ultrasound, Infusion, System

Product code

NUI

Device name

Ultrasound, Infusion, System

Device class

Class 2

21 CFR

21 CFR 870.1200

Medical specialty

Cardiovascular

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).