Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K062342
    Device Name
    TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT
    Date Cleared
    2006-09-25

    (45 days)

    Product Code
    Regulation Number
    870.2850
    Why did this record match?
    Applicant Name (Manufacturer) :

    SENTRA MEDICAL DEVICES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sentra's 'TruePulse' Invasive Pressure Monitoring Kits are indicated for use in physiological, invasive pressure measurement, and are for use with patients requiring intravascular pressure monitoring.
    Device Description
    Sentra's 'TruePulse' Invasive Pressure Monitoring Kits are indicated for use in physiological, invasive pressure measurement, and are for use with patients requiring intravascular pressure monitoring. The True Pulse Disposable Blood Pressure Kit from Sentra medical devices LLC consists of a Arterial extension line (available in various standard lengths) is attached via a luer connection to the catheter that is inserted into the patient, (the male portion of the lumen is a part of the kit and the female portion of the lumen is a part of the catheter is not a part of this device) a stopcock, a monitoring line, to another stopcock, a transducer, a continuous flow flush device, and an IV set all connected by standard luer connections. The device functions by continuously monitoring changes in blood pressure from the function of the heart. The pressure waves generated in the heart are transmitted through the vacult of system, to the catheter and then through the saline fluid - filled tubing to a transducer. Up on reaching the transducer, pressure waves from the fluid pathway depress a diaphragm, changing the resistance to the flow of current through a circuit. The change in resistance produces an electrical event that creates a signal that is then transmitted t o a monitor through a cable and displaying pressure reading and a wave form on a monitor. (The cather and monitor are not parts of this kit).
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1