FDA 510(k) Applications Submitted by Fresenius Kabi AG

FDA 510(k) Number Submission Date Device Name Applicant
K192150 08/09/2019 AMICUS Separator System Fresenius Kabi AG
K160735 03/17/2016 CATSmart FRESENIUS KABI AG
K180831 03/30/2018 CATSmart Fresenius Kabi AG
K121613 06/01/2012 AGILIA INFUSION SYSTEM FRESENIUS KABI AG
K210089 01/13/2021 CATSmart, Automated Blood Processing Autotransfusion System Fresenius Kabi AG
K210073 01/12/2021 Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo Fresenius Kabi AG
K210074 01/12/2021 Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable Fresenius Kabi AG
K210075 01/12/2021 Vigilant Software Suite û Vigilant Master Med Fresenius Kabi AG
K212445 08/05/2021 freeflex+ Transfer Adapter Fresenius Kabi AG
K200530 03/02/2020 AMICUS Separator System Fresenius Kabi AG
K192368 08/30/2019 CATSmart Fresenius Kabi AG


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