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

    SILICONE OIL 350 CNETISTOKE

    K Number: K854273 · Decision Nov 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    128
    Applicant Total
    1
    Review Days
    63

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    Basic Information

    Device Name
    SILICONE OIL 350 CNETISTOKE
    K Number
    K854273
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Pacific Medical Industries
    Date Received
    September 20, 1985
    Decision Date
    November 22, 1985
    Product Code
    KRD
    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
    KRD Device, Vascular, For Promoting Embolization

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