ClaveQS™ Bag
FDA 510(k) clearance K251980 · decided 2026-03-20
Clearance details
- K-number
- K251980
- Device name
- ClaveQS™ Bag
- Applicant
- Icu Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-27
- Decision date
- 2026-03-20
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- KPE
- Device class
- 2
- Regulation number
- 880.5025
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Clemente, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.