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

    HEPARIN COATED THERMODILUTION CATHETER

    K Number: K821099 · Decision May 18, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    3
    Review Days
    28

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    Basic Information

    Device Name
    HEPARIN COATED THERMODILUTION CATHETER
    K Number
    K821099
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Kma, Inc.
    Date Received
    April 20, 1982
    Decision Date
    May 18, 1982
    Product Code
    DYG
    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
    DYG Catheter, Flow Directed

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    Other Clearances by Kma, Inc.

    K Number Device Name
    K850395 THE FEVER-THERM A THERM. MEASURING DEVICE
    K800836 KMA FLOW DIRECTED THERMODILUTION CATHETE