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

    MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER

    K Number: K905080 · Decision Jan 31, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    64
    Applicant Total
    66
    Review Days
    79

    Basic Information

    Device Name
    MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER
    K Number
    K905080
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
    Date Received
    November 13, 1990
    Decision Date
    January 31, 1991
    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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