# Ultrasound, Infusion, System
> **Product code: NUI** · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1200
## Classification
- **FDA Product Code:** NUI
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 870.1200
- **Review panel:** NE
- **Medical specialty:** Cardiovascular
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NUI)
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