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

    BALLOON THERMODILUTION CATHETERS

    K Number: K894401 · Decision Apr 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    3
    Review Days
    304

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    Basic Information

    Device Name
    BALLOON THERMODILUTION CATHETERS
    K Number
    K894401
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Worldwide Medical
    Date Received
    June 19, 1989
    Decision Date
    April 19, 1990
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Worldwide Medical

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