Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K112448
    Device Name
    PULSIOFLEX
    Manufacturer
    PULSION MEDICAL SYSTEMS, INC.
    Date Cleared
    2011-09-22

    (28 days)

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

    PULSION MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    With the optional CeVox™ oximetry module connected to a compatible PulsioFlex oximetry probe, PulsioFlex measures oxygen saturation to assess oxygen delivery in adults.
    Device Description
    PulsioFlex Monitoring System with Optional CeVox ™ Accessories
    Ask a Question
    K Number
    K001762
    Device Name
    PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM
    Manufacturer
    PULSION MEDICAL SYSTEMS, INC.
    Date Cleared
    2000-06-13

    (4 days)

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

    PULSION MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    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?
    Applicant Name (Manufacturer) :

    PULSION MEDICAL SYSTEMS, INC.

    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.
    Ask a Question

    Page 1 of 1