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

    CAROTID ARTERY CLAMP & TOOLS

    K Number: K811821 · Decision Sep 24, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    18
    Review Days
    87

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    Basic Information

    Device Name
    CAROTID ARTERY CLAMP & TOOLS
    K Number
    K811821
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5175
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    New England Surgical Instrument Corp.
    Date Received
    June 29, 1981
    Decision Date
    September 24, 1981
    Product Code
    HCE
    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
    HCE Clamp, Carotid Artery

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    K880859 SURGICAL BURS
    K872271 VARIOUS SIZES & STYLES OF MONOPOLAR FORCEPS
    K872209 ARTHROPLASTY MALLET
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