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

    SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER

    K Number: K910429 · Decision Jul 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    63
    Applicant Total
    505
    Review Days
    160

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    Basic Information

    Device Name
    SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
    K Number
    K910429
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2870
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    February 1, 1991
    Decision Date
    July 11, 1991
    Product Code
    DXO
    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
    DXO Transducer, Pressure, Catheter Tip

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