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510(k) Data Aggregation

    K Number
    K103347
    Device Name
    CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
    Manufacturer
    INTERVASCULAR, SAS
    Date Cleared
    2011-02-02

    (79 days)

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

    INTERVASCULAR, SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Woven Collagen Coated Vascular Prostheses are indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive diseases of the aorta, both thoracic and abdominal, visceral arteries, and proximal peripheral arteries . Due to the low porosity of Woven vascular grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
    Device Description
    Not Found
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