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

    TAKA ANEURYSM CLIP

    K Number: K972750 · Decision Jul 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    35
    Applicant Total
    8
    Review Days
    351

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    Basic Information

    Device Name
    TAKA ANEURYSM CLIP
    K Number
    K972750
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    V. Mueller Neuro/Spine
    Date Received
    July 23, 1997
    Decision Date
    July 9, 1998
    Product Code
    HCH
    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
    HCH Clip, Aneurysm

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