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510(k) Data Aggregation

    K Number
    K112203
    Device Name
    COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST
    Manufacturer
    MIRADOR BIOMEDICAL, INC.
    Date Cleared
    2011-12-14

    (135 days)

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

    MIRADOR BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Compass™ GP disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure. The Compass™ Thoracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure. The Compass™ Paracentesis disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure. The Compass™ Compartment Pressure disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure. The Compass™ Epidural Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure. The Compass™ Arterial Assist disposable pressure transducer with integrated digital display is intended for direct measurement of physiological pressure.
    Device Description
    The Compass devices are disposable, point-of-use pressure measurement and monitoring devices that incorporate a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The Compass devices are designed to attach distally to an inserted needle or catheter, measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD.
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    K Number
    K103715
    Device Name
    COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
    Manufacturer
    MIRADOR BIOMEDICAL, INC.
    Date Cleared
    2011-01-20

    (30 days)

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

    MIRADOR BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K101518
    Device Name
    COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE
    Manufacturer
    MIRADOR BIOMEDICAL, INC.
    Date Cleared
    2010-10-13

    (133 days)

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

    MIRADOR BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Compass™ Vascular Access is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of invasive blood pressure. The Compass™ Lumbar Puncture is a disposable pressure transducer with integrated digital display intended for direct measurement and monitoring of intracranial pressure.
    Device Description
    The Compass is a disposable, point-of-use pressure measurement and monitoring device that incorporates a pressure transducer and an integrated pre-programmed diagnostic computer with liquid crystal display (LCD). The Compass is provided as two different models, each corresponding to a specific indication for use: - (1) The Compass Vascular Access (VA) is for invasive blood pressure measurement and monitoring during the insertion of vascular access devices. - (2) The Compass Lumbar Puncture (LP) is for intracranial pressure measurement and monitoring via lumbar puncture or intraventricular catheter. Both models are designed to attach distally to an inserted needle or catheter, measure the pressure via an embedded pressure sensor, internally convert changes in pressure into electrical currents, and then display the resulting pressure via the integrated LCD. The Compass VA and Compass LP devices are identical except for two differences: 1) the measurement units in which the pressure is displayed on the LCD (mm Hg for blood pressure measurements with the Compass VA and cm H2O for intracranial pressure measurements with the Compass LP), and 2) the Compass VA blood pressure monitoring device has a proximal port through which commercially available guidewires can be inserted during pressure measurement.
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