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510(k) K251980

ClaveQS™ Bag by Icu Medical, Inc. — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2026
Date Received
June 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type

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