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

    Occlusion Balloon Catheter

    K Number: K183679 · Decision Apr 24, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    89
    Applicant Total
    5
    Review Days
    117

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    Basic Information

    Device Name
    Occlusion Balloon Catheter
    K Number
    K183679
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Qxmedical, LLC
    Date Received
    December 28, 2018
    Decision Date
    April 24, 2019
    Product Code
    MJN
    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
    MJN Catheter, Intravascular Occluding, Temporary

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