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510(k) Data Aggregation

    K Number
    K173012
    Device Name
    ANGIO-PRESS LITE DVT Compression Device
    Date Cleared
    2018-05-10

    (225 days)

    Product Code
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pegasus Medical Supply, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pegasus Medical Supply Inc. ANGIO-PRESS LITE DVT Compression Device is intended to increase venous blood flow in patients in order to help prevent deep vein thrombosis.
    Device Description
    The ANGIO-PRESS LITE DVT Compression Device is a non-invasive intermittent pneumatic compression system that aids in prevention and reduction in incidence of deep vein thrombosis (DVT). The system consists of a pump and soft pliable compression single patient use garments for leg or foot compression. The pump supplies compression on a pre-set inflation pressure of 40mmHg for calf and thigh compression, and 80mmHg for foot compression. Pressure in the garments is transferred to the extremities, augmenting venous blood flow, thus reducing stasis.
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    K Number
    K143202
    Device Name
    ANGIO-PRESS DVT Compression Device Model Name: IPCS
    Date Cleared
    2015-07-07

    (242 days)

    Product Code
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pegasus Medical Supply, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pegasus Medical Supply Inc. ANGIO-PRESS IPCS Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in patients in order to help prevent deep vein thrombosis.
    Device Description
    ANGIO-PRESS DVT Compression Device that counteracts blood stasis and coagulation changes - two of the three major factors that promote deep vein thrombosis (DVT). ANGIO-PRESS DVT Compression Device is a non-invasive mechanical prophylactic system that massages the legs in a wavelike, milking motion that promotes blood flow and deters thrombosis, helping to empty pooled or static blood from the valve cusps of the femoral vein. Fibrinolytic activity is increased, stimulating the release of a plasminogen activator. This therapy typically complements other prophylactic measures, such as ant embolic stockings and anticoagulants. ANGIO-PRESS DVT Compression Device is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. Therefore, ANGIO-PRESS DVT Compression Device is identified as a compressible limb sleeve.
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