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

    LOW FLOW OSV II HYDROCEPHALUS VALVE

    K Number: K042192 · Decision Sep 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    6
    Review Days
    21

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    Basic Information

    Device Name
    LOW FLOW OSV II HYDROCEPHALUS VALVE
    K Number
    K042192
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Integra Neurosciences Implants S.A.
    Date Received
    August 12, 2004
    Decision Date
    September 2, 2004
    Product Code
    JXG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JXG Shunt, Central Nervous System And Components

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    Other Clearances by Integra Neurosciences Implants S.A.

    K Number Device Name
    K081773 OSV II
    K042558 EQUI-FLOW VALVE AND SHUNT SYSTEM
    K040201 MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
    K033698 CONTOUR-FLEX VALVE AND SHUNT SYSTEM
    K032817 EXTERNAL DRAINAGE SET