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

    FOGARTY-CHIN PERIPHERAL DILATION CATH

    K Number: K832474 · Decision Sep 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    399
    Applicant Total
    89
    Review Days
    65

    Basic Information

    Device Name
    FOGARTY-CHIN PERIPHERAL DILATION CATH
    K Number
    K832474
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    AMERICAN EDWARDS LABORATORIES
    Date Received
    July 26, 1983
    Decision Date
    September 29, 1983
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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