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

    CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR

    K Number: K925444 · Decision Jul 19, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    1
    Review Days
    264

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    Basic Information

    Device Name
    CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR
    K Number
    K925444
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ami-Med Corp.
    Date Received
    October 28, 1992
    Decision Date
    July 19, 1993
    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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