EKOS MICRO-INFUSION SYSTEM
FDA 510(k) clearance K053437 · decided 2006-01-06
Clearance details
- K-number
- K053437
- Device name
- EKOS MICRO-INFUSION SYSTEM
- Applicant
- Ekos Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-09
- Decision date
- 2006-01-06
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- NUI
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NEUROWAVE MICRO-INFUSION SYSTEM (K062508) | Ekos Corp. | 2006-12-05 |
| EKOS MICRO-INFUSION SYSTEM (K051225) | Ekos Corp. | 2005-06-10 |
| EKOS ULTRASOUND INFUSION SYSTEM (K041826) | Ekos Corp. | 2005-04-27 |
Recalls involving this device
No recalls on record reference this clearance.