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

    Compass Cast and MAP

    K Number: K161408 · Decision Nov 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    147
    Applicant Total
    2
    Review Days
    186

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    Basic Information

    Device Name
    Compass Cast and MAP
    K Number
    K161408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2850
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Centurion Medical Products Corporation
    Date Received
    May 20, 2016
    Decision Date
    November 22, 2016
    Product Code
    DRS
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DRS Transducer, Blood-Pressure, Extravascular

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    Other Clearances by Centurion Medical Products Corporation

    K Number Device Name
    K103562 CENTURION PRESSURE INJECTABLE EXTENSION SET