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510(k) Data Aggregation

    K Number
    K122612
    Device Name
    HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Date Cleared
    2012-09-10

    (14 days)

    Product Code
    MAL
    Regulation Number
    870.3450
    Why did this record match?
    Product Code :

    MAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HEMASHIELD Vascular Grafts are indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
    Device Description
    The HEMASHIELD Vascular Grafts are Woven Double Velour polvester grafts impregnated with highly purified collagen. The HEMASHIELD Vascular Grafts are designed to reduce . bleeding at implant and thereby eliminate the operative preclotting step. The collagen is designed to be gradually resorbed by the patient. In addition to collagen, the grafts also contain glycerol as a softening agent.
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    K Number
    K103080
    Device Name
    ALBOGRAFT VASCULAR PROSTHESIS
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2011-01-19

    (92 days)

    Product Code
    MAL
    Regulation Number
    870.3450
    Why did this record match?
    Product Code :

    MAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AlboGraft Double Velour Knitted or Woven Vascular Prosthesis (peripheral indication) are indicated for use in the replacement or repair of arteries affected with aneurismal or occlusive disease.
    Device Description
    Albograft Vascular Prosthesis is a knitted/woven tubular polyester fabric, impregnated with bovine collagen.
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    K Number
    K093231
    Device Name
    ALBOGRAFT VASCULAR PROSTHESIS
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Date Cleared
    2010-01-14

    (92 days)

    Product Code
    MAL
    Regulation Number
    870.3450
    Why did this record match?
    Product Code :

    MAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AlboGraft Double Velour Knitted and Woven Grafts are indicated for use in the replacement or repair of Abdominal and Thoracic affected with aneurysmal or occlusive disease.
    Device Description
    Not Found
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    K Number
    K052302
    Device Name
    HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2005-09-12

    (19 days)

    Product Code
    MAL
    Regulation Number
    870.3450
    Why did this record match?
    Product Code :

    MAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HEMASHIELD PLATINUM™ Vascular Graft is indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
    Device Description
    The Hemashield Platinum WDV grafts are woven double velour vascular grafts impregnated with a highly purified collagen. The Hemashield Platinum WDV grafts minimize bleeding at implant and thereby eliminate the operative preclotting step, including cumbersome autoclave techniques. The collagen is gradually resorbed by the patient. The CONCENTRICRIMP® pleat and GUIDELINE® are also featured. In addition to collagen, the graft also contains glycerol as a softening agent.
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    K Number
    K021213
    Device Name
    MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2002-04-19

    (2 days)

    Product Code
    MAL
    Regulation Number
    870.3450
    Why did this record match?
    Product Code :

    MAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemashield Platinum vascular grafts are indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
    Device Description
    Not Found
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    K Number
    K954848
    Device Name
    HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Date Cleared
    1996-02-01

    (101 days)

    Product Code
    MAL, 74M
    Regulation Number
    870.3450
    Why did this record match?
    Product Code :

    MAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. which is substantially equivalent to the currently marketed devices.
    Device Description
    The HEMASHIELD® CARDIOVASCULAR GRAFTS are knitted and woven polyester grafts. impregnated with bovine collagen.
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