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

    BAIM TM CORONARY SINUS FLOW THERMAL

    K Number: K810360 · Decision Mar 11, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    35
    Review Days
    29

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    Basic Information

    Device Name
    BAIM TM CORONARY SINUS FLOW THERMAL
    K Number
    K810360
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Electro-Catheter Corp.
    Date Received
    February 10, 1981
    Decision Date
    March 11, 1981
    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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