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510(k) Data Aggregation

    K Number
    K031599
    Device Name
    CD LEYCOM PRESSURE/VOLUME CATHETERS
    Manufacturer
    CD LEYCOM BV
    Date Cleared
    2003-12-09

    (202 days)

    Product Code
    DQODRODXO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    CD LEYCOM BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pressure, Volume and Pressure-Volume catheters are intended for use with the CFL 512 in conjunction with a pressure interface module during catheterization where the quantitative assessment of Left Ventricular function is desired. Refer to the CFL 512 User Manual for a detailed description of the need for pressure and volume measurements in the clinical setting.
    Device Description
    Not Found
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    K Number
    K030524
    Device Name
    CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN
    Manufacturer
    CD LEYCOM BV
    Date Cleared
    2003-03-03

    (12 days)

    Product Code
    OBJ
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    CD LEYCOM BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pressure, Volume and Pressure-Volume catheters are intended for use with the CFL 512 in conjunctions with a pressure interface module during catheterisation laboratory procedures where the quantitative assessment of Left Ventricular function is desired. Refer to the CFL 512 User Manual for a detailed description of the need for pressure and volume measurements in the clinical setting.
    Device Description
    Not Found
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    K Number
    K003020
    Device Name
    CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER
    Manufacturer
    CD LEYCOM BV
    Date Cleared
    2001-05-11

    (226 days)

    Product Code
    DQODRQDXO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    CD LEYCOM BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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