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510(k) Data Aggregation

    K Number
    K021547
    Device Name
    FLOWLINE BIOPORE EPTFE VASCULAR GRAFT
    Manufacturer
    Date Cleared
    2003-01-24

    (259 days)

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

    JOTEC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Jotec FlowLine Bipore ePTFE Vascular Graft is indicated in cases of arterial vasoreconstruction, primarily in the peripheral vascular region. It can also be used in extraanatomical reconstructions - femorofemoral and axillofemoral. Standard Wall FlowLine Bipore ePTFE Vascular Grafts are also indicated for use as arteriovenous shunt prostheses in hemodialysis.
    Device Description
    The Jotec FlowLine Bipore ePTFE Vascular Graft is a tube composed of pure expanded polytetrafluoroethylene (ePTFE). The graft may also have an external line or other orientation mark and may also have an external FEP double helix support. The Jotec FlowLine Bipore ePTFE Vascular Graft is composed of pure expanded polytetrafluoroethylene (ePTFE), as are the predicate devices. Like the predicate devices, the Jotec FlowLine Bipore ePTFE Vascular Graft may have an external support, and an external line or other orientation mark.
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