DeviceClearance

Product code NUI— Cardiovascular

EKOS MICRO-INFUSION SYSTEM

Classification name
Ultrasound, Infusion, System
Device class
Class 2
Regulation
21 CFR 870.1200
Advisory panel
Cardiovascular
Total cleared
4
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code NUI under 21 CFR 870.1200, via openFDA

Market context for product code NUI

FDA has cleared 4 devices under product code NUI between 2005 and 2006, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NUI

Recent clearances under product code NUI

Data sourced from openFDA. This site is unofficial and independent of the FDA.