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

    SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER

    K Number: K974726 · Decision Mar 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    69
    Same Product Code
    257
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER
    K Number
    K974726
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5550
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elekta Implants, SA
    Date Received
    December 18, 1997
    Decision Date
    March 18, 1998
    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 Elekta Implants, SA

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    K971799 PRECISION FLOW OSV II