NUIClass II
Ultrasound, Infusion, System
Cardiovascular · 21 CFR 870.1200
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.
MDR events3All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances4All time
Recent MDR events
3 adverse event reports on file
Event type breakdown
Malfunction3
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
4 clearances for this product code