BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SHERPA PAK TRANSPORTER

    K Number: K133694 · Decision May 23, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    42
    Applicant Total
    7
    Review Days
    171

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    Basic Information

    Device Name
    SHERPA PAK TRANSPORTER
    K Number
    K133694
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5880
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paragonix Technologies, Inc.
    Date Received
    December 3, 2013
    Decision Date
    May 23, 2014
    Product Code
    KDN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KDN System, Perfusion, Kidney

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    Other Clearances by Paragonix Technologies, Inc.

    K Number Device Name
    K254305 BAROguard Donor Lung Preservation System
    K180194 SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
    K143054 Sherpa Pak Kidney Transport System
    K143074 Sherpa Pak Cardiac Transport System
    K133432 SHERPA PAK CARDIAC TRANSPORT SYSTEM
    K123326 SHERPA PAK CARDIAC TRANSPORT SYSTEM