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

    TRANSLUMINAL ENDARTERECTOMY DEVICE

    K Number: K884154 · Decision Dec 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    56
    Applicant Total
    6
    Review Days
    85

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    Basic Information

    Device Name
    TRANSLUMINAL ENDARTERECTOMY DEVICE
    K Number
    K884154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Thomas J. Fogarty, M.D.
    Date Received
    October 3, 1988
    Decision Date
    December 27, 1988
    Product Code
    LIF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LIF Dialyzer Reprocessing System

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    Other Clearances by Thomas J. Fogarty, M.D.

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    K902453 OSCILLOMETRIC PULSE DETECTION DEVICE
    K831809 FOGARTY OCCLUDER PAD
    K841310 GASTROINTESTINAL DILATOR
    K834451 COAXIAL BALLOON GASTROESOPHAGEAL DILA
    K831384 COAXIAL BALLOON URETHRAL DILATOR