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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name centrifuges (micro, ultra, refrigerated) for clinical use
510(k) Number BK060010
Tradename COBE Angel Whole Blood Separation System
Device Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Original Applicant
COBE Cardiovascular, Inc.
14401 west 65th way
arvada,  CO  80004 3599
Regulation Number862.2050
Classification Product Code
JQC  
Date Received02/02/2006
Decision Date 02/27/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type 510(k) Special
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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