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

    FLOCONTROL , MODEL 1028

    K Number: K090970 · Decision Jun 12, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    89
    Applicant Total
    2
    Review Days
    67

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    Basic Information

    Device Name
    FLOCONTROL , MODEL 1028
    K Number
    K090970
    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
    April 6, 2009
    Decision Date
    June 12, 2009
    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
    K023914 COAXIA FLOCONTROL CATHETER