BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇬 Egypt

    Amecath Peripheral inserted Central Venous Catheter Sets

    K Number: K152819 · Decision Feb 5, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    6
    Review Days
    130

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    Basic Information

    Device Name
    Amecath Peripheral inserted Central Venous Catheter Sets
    K Number
    K152819
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ameco Medical Industries
    Date Received
    September 28, 2015
    Decision Date
    February 5, 2016
    Product Code
    LJS
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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    Other Clearances by Ameco Medical Industries

    K Number Device Name
    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
    K110793 AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS