NUI
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Ultrasound, Infusion, System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Medical specialty
- Cardiovascular
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NEUROWAVE MICRO-INFUSION SYSTEM (K062508) | Ekos Corp. | 2006-12-05 |
| EKOS MICRO-INFUSION SYSTEM (K053437) | Ekos Corp. | 2006-01-06 |
| EKOS MICRO-INFUSION SYSTEM (K051225) | Ekos Corp. | 2005-06-10 |
| EKOS ULTRASOUND INFUSION SYSTEM (K041826) | Ekos Corp. | 2005-04-27 |
Track NUI automatically
Every clearance here is in the API, with alerts when new ones post.