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510(k) Data Aggregation

    K Number
    K093915
    Device Name
    DEKA TAC DEVICE
    Date Cleared
    2011-08-23

    (609 days)

    Product Code
    Regulation Number
    876.5820
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    Product Code :

    FIG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DEKA TAC is an automatic tubing clamp device intended for use in a clinical facility as an accessory to a hemodialysis blood circuit to automatically clamp the blood flow in the hemodialysis circuit upon detection of tension in the venous access line in excess of a pre-defined threshold value. The DEKA TAC may be mounted on, or removed from, already assembled hemodialysis blood circuits.
    Device Description
    The DEKA TAC is a multiple-use safety device designed to be used during hemodialysis treatments. The device mounts near the fistula needle on the patient and is designed to clip over the fistula needle tubing. It is designed to occlude the blood flow in the venous blood line should the blood circuit tubing get tangled or tugged or the fistula needle tubing rotated beyond a threshold limit. It will automatically occlude the line once tension, exceeding a pre-established value, is presented to the tubing with a threshold lower than what is required to extract the needle. This occlusion will prevent blood loss should the force on the tubing be great enough to cause the needle to be partially or fully removed from the patient.
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