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510(k) Data Aggregation

    K Number
    K033615
    Device Name
    WFSI'S REPROCESSED COMPRESSION SLEEVE DEVICES
    Date Cleared
    2004-02-13

    (88 days)

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

    WHEATON FRANCISCAN SERVICES INC., SUPPLY CHAIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Wheaton Franciscan Huntleigh Reprocessed Compression Sleeve is recommended for use in whom The Wheath Flanciscan Trancisco Compression Compresses of the prevention of deep vein external compression theraly using the riaming. I to the presence of risk factors for thrombus formation. Intrathromoosis and resuming pumitonaly indicated, sometimes adjunctively with medical measures, during operative compression therepy d general surgery, particularly in patients over the age of 40.
    Device Description
    Huntleigh's compression sleeve device (CSD) is an SUD component of Huntleigh's CSD System. The compression sleeve is an inflatable device generally made of PVC or Polyolefin with a bladder that is attached to a pneumatic compression device called a controller and it is capable of performing multiple low pressure inflation cycles. It is offered in four different sizes that are configured to fit on the patient's thigh or calf (see diagrams in appendix 6). The sleeves are constructed with cells running the length of the patient's thigh or calf that are sequentially inflated and deflated to impart intermittent compression to the respective section of the limb. This "milking" action forces the blood flow in the direction of the heart and prevents back flow of blood. The sleeves are wrapped around the patient's limb and secured with valcor tabs. Because the Huntleigh CSD is placed on the patient's intact skin., it falls under the Spaulding non-critical device classification. The CSD procedure is considered a safe, non invasive, less expensive and simple alternative to anti-coagulant drug therapy and it is one of the least expensive, yet most effective non invasive systems available for the prevention of venous thrombosis. The description of WFSI's Reprocessed Compression Sleeves is substantially equivalent to the above described Huntleigh CSD. The primary descriptive difference between the two products is that WFSI's Reprocessed Compression Sleeves have been reprocessed as several times and are labeled pasteurized and Huntleigh's CSD is a non-sterile product that has not been reprocessed.
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