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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, autotransfusion
510(k) Number K210089
Device Name CATSmart, Automated Blood Processing Autotransfusion System
Applicant
Fresenius Kabi AG
Bad Homburg,  DE 61346
Applicant Contact Deepak Mehta
Correspondent
Fresenius Kabi
Three Corporate Drive
Lake Zurich,  IL  60047
Correspondent Contact Cheryl Chamberlain Roscher
Regulation Number868.5830
Classification Product Code
CAC  
Date Received01/13/2021
Decision Date 02/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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