CATSmart, Automated Blood Processing Autotransfusion System
K-Number: K210089 · 2021-02-11
ApplicantFresenius Kabi AG
Decision Date2021-02-11
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
CATSmart, Automated Blood Processing Autotransfusion System is a medical device manufactured by Fresenius Kabi AG. It received FDA 510(k) clearance on 2021-02-11 under approval number K210089. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CATSmart, Automated Blood Processing Autotransfusion System?
CATSmart, Automated Blood Processing Autotransfusion System is a medical device that received FDA 510(k) clearance on 2021-02-11. It is manufactured by Fresenius Kabi AG. The 510(k) number is K210089.
When was CATSmart, Automated Blood Processing Autotransfusion System approved by the FDA?
CATSmart, Automated Blood Processing Autotransfusion System received FDA 510(k) clearance on 2021-02-11, under approval number K210089.
What company makes CATSmart, Automated Blood Processing Autotransfusion System?
CATSmart, Automated Blood Processing Autotransfusion System is manufactured by Fresenius Kabi AG.
What is the FDA product code for CATSmart, Automated Blood Processing Autotransfusion System?
The FDA product code for CATSmart, Automated Blood Processing Autotransfusion System is CAC.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.