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510(k) Data Aggregation

    K Number
    K011625
    Device Name
    VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)
    Manufacturer
    Date Cleared
    2002-01-23

    (243 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASOCOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vasocor™ Vascular Diagnostic Center (Model 300) is a non-invasive medical device that can be used by physicians and other health care professionals to measure blood pressure values (systolic, diastolic and pulse pressure) and the heart pulse rates based on segmental measurement. The Vascular Diagnostic Center (Model 300) also calculates Framingham coronary heart disease, stroke, and peripheral disease risk scores, body mass index (BMI), oolonary Livel index (ABI), and pressure differentials between certain adjacent peripheral limb segments, and provides indications of arterial compliance. The indications of arterial compliance (that is, elasticity indices) can be used to assist in assessing and managing patients that may have (alarti, crasherly including cardiovascular disease, that might require more specific diagnostic evaluations by physicians or other health care providers.
    Device Description
    The Vasocor Vascular Diagnostic Center (Model 300) is a vascular laboratory that integrates, into one device, various modules that provide indices of significance to peripheral vascular and cardiovascular function. These modules include Patient Data, Framingham and BMI, ABIgram™ Ankle/Brachial Index, PADogram™ Segmental Pressure Analysis, and Vasogram™ Arterial Compliance Procedure. The Vascular Diagnostic Center (Model 300) also offers administrative capabilities such as creating periodic system usage reports which show test dates, procedures performed, patient names, and physician names.
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    K Number
    K990123
    Device Name
    PVR-100/VASOGRAM
    Manufacturer
    Date Cleared
    1999-04-12

    (89 days)

    Product Code
    Regulation Number
    870.2780
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASOCOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PVR-100 / Vasogram is a noninvasive medical device used in conjunction with other devices such as: continuous-wave Doppler ultrasound, treadmill testing, and ultrasonic imaging techniques for vascular studies of the limbs and digits. Use of the PVR-100 / Vasogram in this manner allows the physician to noninvasively diagnosis extremity arterial and venous disorders, and receive, record, and produce a visual display of local arterial compliance.
    Device Description
    The PVR-100 / Vasogram is a noninvasive medical device.
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    K Number
    K973659
    Device Name
    VASOCOR PVR 100
    Manufacturer
    Date Cleared
    1997-12-17

    (83 days)

    Product Code
    Regulation Number
    870.2780
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASOCOR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vasocor PVR-100 (Pulse Volume Recorder) is a non-invasive medical device used in conjunction with other devices such as; continuous-wave Doppler ultrasound, treadmill testing, and ultrasonic imaging techniques for vascular studies of limbs and digits. Use of the PVR in this manner allows the physician to non-invasively diagnosis extremity arterial and venous disorders.
    Device Description
    The Vasocor PVR-100 provides Pulse Volume Recording (PVR) made possible through air plethysmography. The PVR-100 device, which is based on a PC platform, includes various standard blood pressure cuff sizes that allow use of the PVR measurement on various limb and digit extremities, a pneumatic circuit that allows for internal calibration as well as inflation cuff pressure, and a user interface that includes various menus and screens for inputting patient demographic data, performing tests, displaying and entering results, and printing reports. The PVR tracing is accomplished by attaching a standard blood pressure cuff on various areas of the extremities. Once atmospheric air is injected into the cuff to provide skin contact, a pressure transducer records the pressure change in the PVR cuff secondary to change in volume of the extremity segment under the cuff during repeated cardiac cycles. PVR measurement is accomplished by calculating the volume change in the extremity segment under evaluation, where the PVR tracing shows the change in pressure of the same segment during the cardiac cycle.
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