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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K090189
Device Name ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
Applicant
Icu Medical, Inc.
4455 Atherton Dr.
Salt Lake City,  UT  84123
Applicant Contact TRACY BEST
Correspondent
Icu Medical, Inc.
4455 Atherton Dr.
Salt Lake City,  UT  84123
Correspondent Contact TRACY BEST
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
LHI  
Date Received01/26/2009
Decision Date 04/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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