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

    COAXIA FLOCONTROL CATHETER

    K Number: K023914 · Decision Feb 21, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    89
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    COAXIA FLOCONTROL CATHETER
    K Number
    K023914
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coaxia, Inc.
    Date Received
    November 25, 2002
    Decision Date
    February 21, 2003
    Product Code
    MJN
    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
    MJN Catheter, Intravascular Occluding, Temporary

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    Other Clearances by Coaxia, Inc.

    K Number Device Name
    K090970 FLOCONTROL , MODEL 1028