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510(k) Data Aggregation

    K Number
    K990800
    Device Name
    INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS
    Manufacturer
    INTERVASCULAR, INC.
    Date Cleared
    2001-01-08

    (670 days)

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

    INTERVASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InterGard Collagen Coated and Heparin Bonded vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
    Device Description
    The InterGard Knitted Collagen Coated & Heparin Bonded Vascular Prostheses including The InterGard Knitted Ultra-Thin, are Vascular Grafts made of Dacron fabric and coated with bovine collagen. These products are offered in numerous lengths and diameters exceeding 6 mm.
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    K Number
    K984294
    Device Name
    MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
    Manufacturer
    INTERVASCULAR, INC.
    Date Cleared
    1999-02-22

    (83 days)

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

    INTERVASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InterGard Woven collagen coated vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the thoracic and abdominal aorta, visceral arteries, and proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
    Device Description
    InterGard Woven Collagen Coated Vascular Prostheses
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    K Number
    K983819
    Device Name
    INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN
    Manufacturer
    INTERVASCULAR, INC.
    Date Cleared
    1998-11-24

    (26 days)

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

    INTERVASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InterGard Knitted Ultra Thin Vascular Graft - InterGard knitted Ultra Thin collagen coated vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery. HemaCarotid Patch Ultra Thin The HemaCarotid Patch Ultra Thin is indicated for cardiac and vascular patch graft angioplasty. Due to the low porosity of the fabric, these products are recommended for use in patients requiring heparinization prior to or during surgery.
    Device Description
    InterGard™ Knitted Ultra Thin Collagen Coated Vascular Grafts and Patches
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    K Number
    K970843
    Device Name
    INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
    Manufacturer
    INTERVASCULAR, INC.
    Date Cleared
    1997-06-05

    (90 days)

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

    INTERVASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InterGard woven vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
    Device Description
    InterGard™ Woven Collagen Coated Vascular Prostheses
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    K Number
    K964625
    Device Name
    HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES
    Manufacturer
    INTERVASCULAR, INC.
    Date Cleared
    1997-05-05

    (171 days)

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

    INTERVASCULAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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