510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NUIClass II

Ultrasound, Infusion, System

21 CFR 870.1200 / Cardiovascular
FDA source (opens on fda.gov)

NUI is the FDA product code for Ultrasound, Infusion, System, a class II device type, regulated under 21 CFR 870.1200. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NUI
Device name
Ultrasound, Infusion, System
FDA 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.
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code NUI

By decision year
4 clearances under product code NUI with a decision year between 2005 and 2006, 2005 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NUI by decision year
YearClearances
20052
20062

Applicants with the most clearances

Product code NUI
Applicants holding the most 510(k) clearances under product code NUI
ApplicantClearances
Ekos Corp.4

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NUI.