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

    DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION

    K Number: K914985 · Decision Dec 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    50
    Applicant Total
    56
    Review Days
    58

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    Basic Information

    Device Name
    DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
    K Number
    K914985
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1390
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    E-Z-Em, Inc.
    Date Received
    October 23, 1991
    Decision Date
    December 20, 1991
    Product Code
    DRC
    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
    DRC Trocar

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