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

    MAHURKAR TRIPLE LUMEN CATHETER, 12 FR

    K Number: K020089 · Decision Apr 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    11
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
    K Number
    K020089
    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
    January 10, 2002
    Decision Date
    April 10, 2002
    Product Code
    NIE
    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
    NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted

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