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

    MiniGuard Arterial Safety Valve

    K Number: K182442 · Decision Nov 6, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    8
    Applicant Total
    39
    Review Days
    60

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    Basic Information

    Device Name
    MiniGuard Arterial Safety Valve
    K Number
    K182442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quest Medical, Inc.
    Date Received
    September 7, 2018
    Decision Date
    November 6, 2018
    Product Code
    MJJ
    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
    MJJ Cpb Check Valve, Retrograde Flow, In-Line

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