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510(k) Data Aggregation

    K Number
    K192869
    Device Name
    SherpaPak Lung Preservation System , SherpaPak Liver Transport System
    Manufacturer
    Pragonix Technologies
    Date Cleared
    2020-01-16

    (101 days)

    Product Code
    KDN
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pragonix Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Paragonix SherpaPak™ Lung Preservation System is intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for the Paragonix SherpaPak™ Lung Preservation System is up to 8 hours. Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient. Note: Partial lungs can be transported via SherpaPak™ LPS by packaging lungs per institutional protocol and UNOS guidelines. The Paragonix SherpaPak™ Liver Transport System is intended to be used for the static hypothermic preservation of livers during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the livers. The intended organ storage time for the Paragonix SherpaPak™ Liver Transport System is up to 15 hours. Donor livers exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplance with accepted clinical guidelines and in the best medical interest of the intended recipient.
    Device Description
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