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

    URESIL OCCLUSION BALLOON CATHETER

    K Number: K863559 · Decision Oct 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    45
    Review Days
    28

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    Basic Information

    Device Name
    URESIL OCCLUSION BALLOON CATHETER
    K Number
    K863559
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1370
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Uresil Corp.
    Date Received
    September 12, 1986
    Decision Date
    October 10, 1986
    Product Code
    DQT
    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
    DQT Occluder, Catheter Tip

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