K251980
- 510(k) number
- K251980
- Device name
- ClaveQS Bag
- Applicant
- Icu Medical, Inc. CA · US
- Product code
- KPE — Container, I.V.
- Decision date
- 2026-03-20
- Date received
- 2025-06-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K251980.pdf
Official FDA record: K251980
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.