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

    THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003

    K Number: K032920 · Decision Dec 16, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    1
    Review Days
    85

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    Basic Information

    Device Name
    THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003
    K Number
    K032920
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Coeur Medical
    Date Received
    September 22, 2003
    Decision Date
    December 16, 2003
    Product Code
    DXT
    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
    DXT Injector And Syringe, Angiographic

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