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

    AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS

    K Number: K110793 · Decision Dec 16, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    37
    Applicant Total
    6
    Review Days
    269

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    Basic Information

    Device Name
    AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS
    K Number
    K110793
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ameco Medical Industries
    Date Received
    March 22, 2011
    Decision Date
    December 16, 2011
    Product Code
    MPB
    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
    MPB Catheter, Hemodialysis, Non-Implanted

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    Other Clearances by Ameco Medical Industries

    K Number Device Name
    K152819 Amecath Peripheral inserted Central Venous Catheter Sets
    K131144 AMECO SHEATH INTRODUCER
    K131814 AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER
    K123943 AMECATH DUAL LUMEN HEMODIALYSIS CATHETER
    K110794 AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS