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

    HEIFETZ INTRACRANIAL ANEURYSM CLIPS

    K Number: K832795 · Decision Nov 25, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    35
    Applicant Total
    140
    Review Days
    99

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    Basic Information

    Device Name
    HEIFETZ INTRACRANIAL ANEURYSM CLIPS
    K Number
    K832795
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5200
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Edward Weck, Inc.
    Date Received
    August 18, 1983
    Decision Date
    November 25, 1983
    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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