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    K Number
    K171620
    Device Name
    PiCCO Catheter
    Manufacturer
    PULSION Medical Systems SE
    Date Cleared
    2018-02-21

    (264 days)

    Product Code
    KRB
    Regulation Number
    870.1915
    Why did this record match?
    Product Code :

    KRB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PiCCO Catheters are used as accessories for thermodilution and arterial blood pressure measurement. PiCCO Catheters are 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 are undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.
    Device Description
    The PiCCO Catheter uses a thermistor to measure the blood temperature change during thermodilution. This thermistor is located in one of the two catheter lumen. The second catheter lumen ends in a Luer-Lock for connection to a pressure monitoring kit. The thermistor is connected to a patient monitor via a dedicated plug. The placement of the catheter into a large arterial vessel is done using the Seldinger Technique and is intended to use of up to 10 days. The PiCCO Catheter Sets contain the following parts: 1. PiCCO Catheter, 2. Guidewire with dispenser and advancer, 3. Introducer needles, 4. Dilator (exception: the 3F Set does not include a dilator). Five PiCCO Catheter models are available which differ in diameter and length. The PiCCO catheter set contains accessories fitting to the respective PiCCO catheter model in size. The Catheter Set is packed into a preformed blister (PET), sealed with a Tyvek® lid and EtO sterilized.
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    K Number
    K100739
    Device Name
    VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
    Manufacturer
    EDWARDS LIFESCIENCES, LLC.
    Date Cleared
    2010-12-07

    (266 days)

    Product Code
    KRB
    Regulation Number
    870.1915
    Why did this record match?
    Product Code :

    KRB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VolumeView system is indicated for use in critical care patients in which cardio-respiratory function, fluid status, and vascular resistance need constant and/or intermittent assessment. The femoral arterial catheter is indicated for femoral artery insertion.
    Device Description
    The VolumeView System consists of a 4 or 5 French, 16 or 20 cm, two lumen femoral artery catheter and a CVC thermistor manifold. One catheter lumen has a thermistor for making blood temperature measurements, and the other is used for pressure monitoring. The manifold is used for injecting thermodilution boli through a central venous catheter. The guidewire is a PTFE-coated nitinol guidewire.
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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?
    Product Code :

    KRB

    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
    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?
    Product Code :

    KRB

    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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    K Number
    K991886
    Device Name
    PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
    Manufacturer
    PULSION MEDICAL SYSTEMS, INC.
    Date Cleared
    2000-05-11

    (344 days)

    Product Code
    KRB
    Regulation Number
    870.1915
    Why did this record match?
    Product Code :

    KRB

    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 monitorinq is desired and patients undergoing surgical interventions of such magnitude that cardiovascular monitoring is necessary.
    Device Description
    The PULSION Pulsiocath Thermodilution Catheter with J-Guidewire and needle, and a monitoring kit including an in-line injectate sensor used as accessories to the Pulsion Continuous Pulse Contour Cardiac Output System (PiCCO). When coupled with the Pulsion Continuous Pulse Contour Cardiac Output System (PiCCO), the above device accessories, in connection with a central venous catheter, operate to measure and display cardiac output parameters.
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