BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM

    K Number: K993245 · Decision Oct 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    1
    Review Days
    30

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    Basic Information

    Device Name
    CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM
    K Number
    K993245
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alba Critical Care, Ltd.
    Date Received
    September 28, 1999
    Decision Date
    October 28, 1999
    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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