LYSUS INFUSION SYSTEM
FDA 510(k) clearance K041629 · decided 2004-08-06
Clearance details
- K-number
- K041629
- Device name
- LYSUS INFUSION SYSTEM
- Applicant
- Ekos Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-16
- Decision date
- 2004-08-06
- Days to decision
- 51 days
- Clearance type
- Traditional
- 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.