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510(k) Data Aggregation

    K Number
    K990503
    Device Name
    SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
    Manufacturer
    SULZERMEDICA
    Date Cleared
    1999-12-09

    (295 days)

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

    SULZERMEDICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sulzer Vascutek Gelsoft™ Vascular Prosthesis is indicated for abdominal and peripheral vascular repair, i.e. replacement or bypass in aneurysmal and occlusive disease of arteries.
    Device Description
    The Sulzer Vascutek Gelsoft™ Vascular Prosthesis is a gelatin-sealed, woven polyester graft with a base graft porosity of 2118 ml/cm³/min. The knitted polyester material has been impregnated with an absorbable mammalian gelatin that seals the prosthesis in the same manner as the fibrin deposited in traditional procedures. The gelatin sealant obviates the need for preclotting prior to implantation. The gelatin is of USP standard and is derived from bovine bone sourced exclusively in the United States. The result is a vascular prosthesis that does not require preclotting even when patients have been anticoagulated or when bleeding is a prime concern.
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