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

    SHERPA PAK CARDIAC TRANSPORT SYSTEM

    K Number: K123326 · Decision Feb 6, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    12
    Applicant Total
    7
    Review Days
    103

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    Basic Information

    Device Name
    SHERPA PAK CARDIAC TRANSPORT SYSTEM
    K Number
    K123326
    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
    October 26, 2012
    Decision Date
    February 6, 2013
    Product Code
    MSB
    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
    MSB System And Accessories, Isolated Heart, Transport And Preservation

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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
    K133694 SHERPA PAK TRANSPORTER
    K133432 SHERPA PAK CARDIAC TRANSPORT SYSTEM