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

    AMECO SHEATH INTRODUCER

    K Number: K131144 · Decision Aug 15, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    273
    Registration Numbers
    273
    Same Product Code
    701
    Applicant Total
    6
    Review Days
    114

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    Basic Information

    Device Name
    AMECO SHEATH INTRODUCER
    K Number
    K131144
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ameco Medical Industries
    Date Received
    April 23, 2013
    Decision Date
    August 15, 2013
    Product Code
    DYB
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DYB Introducer, Catheter

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    Other Clearances by Ameco Medical Industries

    K Number Device Name
    K152819 Amecath Peripheral inserted Central Venous Catheter Sets
    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