Ekos Micro-Infusion System
FDA 510(k) K053437 · Ekos Corp.
510(k) numberK053437
Submission
- Device name
- Ekos Micro-Infusion System
- Applicant
- Ekos Corp.
Bothell, WA, US - Received
- December 9, 2005
- Decision date
- January 6, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUI – Ultrasound, Infusion, System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- 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.
Other 510(k)s with product code NUI
More from Ekos Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0)QEY · Special | 08/17/2020SE |
| K111705 | Ekosonic Endovascular SystemQEY · Traditional | 08/03/2011SE |
| K081467 | Ekosonic Endovascular System with Rapid Pulse ModulationQEY · Special | 06/26/2008SE |
| K080392 | EndoWave Infusion SystemQEY · Special | 04/30/2008SE |
| K073166 | Endowave Infusion SystemKRA · Traditional | 04/22/2008SESU |
| K072507 | Endowave Infusion SystemQEY · Special | 10/04/2007SE |
| K071933 | Endowave Infusion SystemQEY · Special | 08/10/2007SE |
| K063620 | Ekos Micro-Infusion SystemQEY · Traditional | 08/06/2007SESU |
| K062508 | Neurowave Micro-Infusion SystemNUI · Special | 12/05/2006SESU |
| K062507 | Micro-Infusion SystemQEY · Special | 11/22/2006SE |
Questions and answers
When was Ekos Micro-Infusion System cleared by the FDA?
Ekos Micro-Infusion System (K053437) received a 510(k) decision of Substantially Equivalent on January 6, 2006, 28 days after the submission was received.
What is the product code of K053437?
The FDA product code is NUI – Ultrasound, Infusion, System, a Class II (moderate risk) device regulated under 21 CFR 870.1200.