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

    ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY

    K Number: K913468 · Decision Mar 24, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    64
    Applicant Total
    190
    Review Days
    962

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    Basic Information

    Device Name
    ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY
    K Number
    K913468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cook, Inc.
    Date Received
    August 5, 1991
    Decision Date
    March 24, 1994
    Product Code
    LFJ
    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
    LFJ Catheter, Subclavian

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