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510(k) Data Aggregation

    K Number
    K094044
    Device Name
    SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT
    Date Cleared
    2010-03-23

    (82 days)

    Product Code
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAYSIDE FLOW TECHNOLOGIES LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Spiral Laminar Flow™ Vascular Arteriovenous Graft is a vascular prosthesis, which is intended for use as a subcutaneous arteriovenous conduit for vascular access during hemodialysis. ONLY trained and qualified physicians and/or surgeons, under the controlled conditions of a hospital operating theatre environment are indicated for use of this device for implantation.
    Device Description
    The TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft is to be used as an arteriovenous conduit for hemodialysis access. The graft has a specially designed section which is intended to induce spiral laminar flow. This section is designed to propagate spiral flow though the graft and into the distal circulation. TFT Spiral Laminar Flow™ Vascular Arteriovenous Graft is manufactured from a straight tubular expanded polytetrafluoroethylene (ePTFE) vascular graft. The straight graft is combined with TFT's unique SLF™ external spiral flow inducer and inducer indicator, both made from ChronoFlex® C-80A; a Biodurable Medical Grade polyurethane. The inducer indicator is a palpable ring over the proximal end of the spiral flow inducer. Its purpose is to indicate to the user where the spiral inducer segment begins since it is intended that cannulation in this segment should be avoided.
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    K Number
    K083169
    Device Name
    EPTFE SLFTM SPIRAL VASCULAR GRAFT
    Date Cleared
    2009-03-30

    (154 days)

    Product Code
    Regulation Number
    870.3450
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAYSIDE FLOW TECHNOLOGIES LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ePTFE SLF™ Spiral Vascular Grafts are indicated for use as vascular prostheses. The device is intended for use in the bypass or reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee. Graft configurations are intended for use as arterial conduits for bypass, or reconstruction of peripheral arterial blood vessels.
    Device Description
    The device is a vascular graft which has a specially designed section intended to induce spiral laminar flow. The grafts are manufactured from a straight tubular expanded polytetrafluoroethylene (ePTFE) vascular graft, supplied by Vascutek Ltd. The graft includes a helical overlay of polytetrafluoroethylene (PTFE) beading, injection moulded onto the external surface of the ePTFE tube. The function of the beading is to provide reinforcement for the tube.
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