Ultrasound, Infusion, System
FDA product code NUI · Class II (moderate risk) · 21 CFR 870.1200 · Cardiovascular
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.
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K062508 | Neurowave Micro-Infusion SystemNUI · Special | Ekos Corp. | 12/05/2006SESU |
| K053437 | Ekos Micro-Infusion SystemNUI · Special | Ekos Corp. | 01/06/2006SE |
| K051225 | Ekos Micro-Infusion SystemNUI · Special | Ekos Corp. | 06/10/2005SESU |
| K041826 | Ekos Ultrasound Infusion SystemNUI · Traditional | Ekos Corp. | 04/27/2005SESU |