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

    MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER

    K Number: K102605 · Decision Dec 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    103

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    Basic Information

    Device Name
    MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER
    K Number
    K102605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Covidien, LLC, Formerly Registered AS Tyco Healthca
    Date Received
    September 10, 2010
    Decision Date
    December 22, 2010
    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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