EndoWave Infusion System
FDA 510(k) clearance K080392 · decided 2008-04-30
Clearance details
- K-number
- K080392
- Device name
- EndoWave Infusion System
- Applicant
- Ekos Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-02-13
- Decision date
- 2008-04-30
- Days to decision
- 77 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
No recalls on record reference this clearance.