BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DISPOSABLE INTRODUCER SHEATH

    K Number: K910079 · Decision Feb 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    231
    Registration Numbers
    231
    Same Product Code
    66
    Applicant Total
    21
    Review Days
    50

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    Basic Information

    Device Name
    DISPOSABLE INTRODUCER SHEATH
    K Number
    K910079
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Applied Vascular Devices, Inc.
    Date Received
    January 8, 1991
    Decision Date
    February 27, 1991
    Product Code
    KDC
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KDC Instrument, Surgical, Disposable

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