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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K251980
Device Name ClaveQS™ Bag
Applicant
Icu Medical, Inc.
951 Calle Amanecer
San Clemente,  CA  92673
Applicant Contact Jeffrey Wan
Correspondent
Icu Medical, Inc.
951 Calle Amanecer
San Clemente,  CA  92673
Correspondent Contact Akash Gouli
Regulation Number880.5025
Classification Product Code
KPE  
Date Received06/27/2025
Decision Date 03/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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