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

    KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER

    K Number: K002901 · Decision Mar 28, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    123
    Applicant Total
    8
    Review Days
    191

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    Basic Information

    Device Name
    KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER
    K Number
    K002901
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Kendall Company
    Date Received
    September 18, 2000
    Decision Date
    March 28, 2001
    Product Code
    MSD
    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
    MSD Catheter, Hemodialysis, Implanted

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