LYSUS INFUSION SYSTEM
FDA 510(k) clearance K060422 · decided 2006-03-09
Clearance details
- K-number
- K060422
- Device name
- LYSUS INFUSION SYSTEM
- Applicant
- Ekos Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-02-17
- Decision date
- 2006-03-09
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- QEY
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters. E recall (Z-0577-2007) | Ekos Corp | 2007-03-08 |