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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 K081361
Device Name CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX
Applicant
ICU MEDICAL INC
4455 ATHERTON DRIVE
SALT LAKE CITY,  UT  84123
Applicant Contact TRACY BEST
Correspondent
ICU MEDICAL INC
4455 ATHERTON DRIVE
SALT LAKE CITY,  UT  84123
Correspondent Contact TRACY BEST
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
LHI  
Date Received05/15/2008
Decision Date 08/28/2008
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
Recalls CDRH Recalls
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