K251980

ClaveQS™ Bag

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.