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510(k) Data Aggregation

    K Number
    K091786
    Device Name
    PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)
    Manufacturer
    PULSION MEDICAL SYSTEMS AG
    Date Cleared
    2010-06-18

    (366 days)

    Product Code
    DXG
    Regulation Number
    870.1435
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULSION MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PULSION PICCO-2 is intended for determination and monitoring of cardiopulmonary and circulatory variables. With the optional CeVOX™ oximetry module connected to a compatible oximetry probe, the PiCCO-2 measures oxygen saturation to assess oxygen delivery and consumption in adults and pediatrics. Cardiac output is determined both continuously through pulse contour analysis and intermittently thermodilution technique. In addition, the PiCCO-2 measures heart rate, systolic, and diastolic and derives mean arterial venous pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for the determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PiCCO-2 monitor presents the derived parameters indexed to body surface area.
    Device Description
    The PULSION PiCCO-2 is a microprocessor-based instrument intended for the determination and monitoring of cardiopulmonary and circulatory variables. When the optional CeVOX™ optical module and probe are connected to the PiCCO-2, the monitor measures oxygen samuation in adults or pediatrics. In addition, the PiCCO-2 measures heart rate, systelic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PiCCO-2 presents the derived parameters indexed to body surface area.
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    K Number
    K072735
    Device Name
    PULSION PICCO-2, MODEL 8500
    Manufacturer
    PULSION MEDICAL SYSTEMS AG
    Date Cleared
    2007-10-18

    (21 days)

    Product Code
    DXG
    Regulation Number
    870.1435
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULSION MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PULSION PiCCO-2 is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PiCCO-2 measures heart rate, systolic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered, the PiCCO-2 presents the derived parameters indexed to body surface area.
    Device Description
    Not Found
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    K Number
    K072364
    Device Name
    PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES
    Manufacturer
    PULSION MEDICAL SYSTEMS AG
    Date Cleared
    2007-09-19

    (28 days)

    Product Code
    KRB
    Regulation Number
    870.1915
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULSION MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulsion Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor are intended for use with the Pulsion PiCCO Cardiac Output System for the measurement of cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis. The Pulsion PiCCO Cardiac Output System with Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line sensor is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, cardiac, and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.
    Device Description
    Not Found
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    K Number
    K060898
    Device Name
    PULSION PICCO PLUS, MODEL 8100
    Manufacturer
    PULSION MEDICAL SYSTEMS AG
    Date Cleared
    2006-07-25

    (113 days)

    Product Code
    DXG
    Regulation Number
    870.1435
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULSION MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PULSION PiCCO Plus is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the PiCCO Plus measures heart rate, systolic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered. the PiCCO Plus presents the derived parameters indexed to body surface area.
    Device Description
    Not Found
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    K Number
    K020587
    Device Name
    PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046
    Manufacturer
    PULSION MEDICAL SYSTEMS AG
    Date Cleared
    2002-05-23

    (90 days)

    Product Code
    KRB
    Regulation Number
    870.1915
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULSION MEDICAL SYSTEMS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PULSION Pulsiocath Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor are intended for use with the PULSION PiCCO Cardiac Output System for the measurement of cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis. The PULSION PiCCO Cardiac Output System with Thermodilution Catheter and Pressure Monitoring Kit with Injectate In-Line Sensor is indicated in patients where cardiovascular and circulatory volume status monitoring is necessary. Such as patients in surgical, medical, cardiac, and burn specialty units as well as other specialty units where cardiovascular monitoring is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.
    Device Description
    The Pulsion Pulsiocath PiCCO Monitoring Kit, Injectate Sensor Temperature Housing PV 4046 is an injectate in-line sensor. The primary modifications are changes to the injectate in-line sensor design, materials, and dimensions. Corresponding dimensional changes have been made to the housing to accommodate additional components and their positioning within the housing resulting from the change.
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