NUI · Class II · 21 CFR 870.1200

FDA Product Code NUI: Ultrasound, Infusion, System

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.

Leading manufacturers include Ekos Corp..

4
Total
4
Cleared
113d
Avg days
2005
Since

FDA 510(k) Cleared Ultrasound, Infusion, System Devices (Product Code NUI)

4 devices
1–4 of 4
Cleared Dec 05, 2006
NEUROWAVE MICRO-INFUSION SYSTEM
K062508
Ekos Corp.
Neurology · 99d
Cleared Jan 06, 2006
EKOS MICRO-INFUSION SYSTEM
K053437
Ekos Corp.
Neurology · 28d
Cleared Jun 10, 2005
EKOS MICRO-INFUSION SYSTEM
K051225
Ekos Corp.
Neurology · 29d
Cleared Apr 27, 2005
EKOS ULTRASOUND INFUSION SYSTEM
K041826
Ekos Corp.
Neurology · 294d

About Product Code NUI - Regulatory Context