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

    TEMPORARY OCCLUSION BALLOON SYSTEM

    K Number: K972777 · Decision Mar 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    88
    Applicant Total
    2
    Review Days
    229

    Basic Information

    Device Name
    TEMPORARY OCCLUSION BALLOON SYSTEM
    K Number
    K972777
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    PERCUSURGE, INC.
    Date Received
    July 25, 1997
    Decision Date
    March 11, 1998
    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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    Other Clearances by PERCUSURGE, INC.

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