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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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    K Number
    K042984
    Device Name
    INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C
    Manufacturer
    INTERVASCULAR
    Date Cleared
    2005-02-18

    (112 days)

    Product Code
    DWF
    Regulation Number
    870.4210
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERVASCULAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InterGard Woven Connector Graft is intended for use in arterial perfusion of the aorta, via femoral or axillary artery, for cardiopulmonary bypass when extracorporeal circulation is required for periods up to six (6.0) hours.
    Device Description
    InterGard Woven Connector Graft
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    K Number
    K022242
    Device Name
    INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER
    Manufacturer
    INTERVASCULAR
    Date Cleared
    2002-08-14

    (34 days)

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

    INTERVASCULAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InterVascular InterGard Knitted Vascular Graft Sizer is an accessory to the InterGard Knitted Vascular Prosthesis and is designed to assist the physician in determining the size of the lumen of the host vessel in order to select the appropriate knitted vascular graft diameter.
    Device Description
    The InterVascular Graft Sizer, an accessory to the InterGard Knitted Vascular Prosthesis, consists of a set of 5 disposable dual gauge sizers and 1 disposable single gauge sizer constructed of a biocompatible material. The size indicated on the instrument approximately corresponds to the size of the lumen of the host vessel. The labeled sizes of the instrument are 6, 7, 8, 10, 12, 14, 16, 18, 20, 22, and 24mm. The surgeon makes the ultimate decision on the size of the graft.
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    K Number
    K013651
    Device Name
    INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS
    Manufacturer
    INTERVASCULAR
    Date Cleared
    2002-02-27

    (113 days)

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

    INTERVASCULAR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    InterGard HemaBridge and InterGard Aortic Arch 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
    Not Found
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    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
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