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510(k) Data Aggregation

    K Number
    K231972
    Device Name
    Advanta VXT Vascular Graft, Flixene Vascular Graft
    Manufacturer
    Atrium Medical Corporation
    Date Cleared
    2024-03-28

    (269 days)

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

    Atrium Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Advanta VXT and Flixene vascular grafts are indicated for use in patients with peripheral vascular disease, where peripheral arteries must be repaired or replaced and open surgery is required. Indications for use also includes patients with end stage renal disease requiring arteriovenous vascular access for dialysis.
    Device Description
    Atrium ePTFE vascular grafts are offered in a variety of designs; (including Advanta VXT and Flixene). They are made primarily of expanded polytetrafluoroethylene (ePTFE), and are available in a wide variety of configurations: - . "Rings" (also referred to as "helix") for added radial support (made from a PTFE monofilament coil) - . The Slider Graft Deployment System consisting of a pre-attached tip(s) with a clear flexible sheath (polyethylene) - . Tapered end - . Thin or standard wall thickness The Advanta VXT graft is a 2-layer graft employing a single-layer ePTFE graft, which is then wrapped with an additional layer of ePTFE for increased support. The rings available on some Advanta VXT grafts are bonded to the exterior surface of the graft. By following the prescribed procedure, the rings can be removed incrementally as needed. The Flixene vascular graft is a 3layer graft comprised of ePTFE. This graft was designed with an additional layer of ePTFE. As a result of its design, ring support is not necessary. Implantable portion of graft is comprised of polytetrafluoroethylene (PTFE) with no more than 0.1% cobalt chromite blue-green Spinel ink on surface of the graft, which is used as a reference line. Additional materials in transient contact during placement of the graft include 303 stainless steel and polyethylene, which represents the graft deployment system and transfer sleeve.
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    K Number
    K201305
    Device Name
    Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
    Manufacturer
    Atrium Medical Corporation
    Date Cleared
    2021-09-03

    (476 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Why did this record match?
    Applicant Name (Manufacturer) :

    Atrium Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    · Evacuate air and/or fluid from the chest cavity or mediastinum. · Help re-establish lung expansion and restore breathing dynamics. Chest Drain Auto transfusion (ATS) To facilitate collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in postoperative and trauma blood loss management.
    Device Description
    Atrium's Auto transfusion (ATS) Chest Drains are sterile, single use, disposable devices that mimic a traditional "3 Bottle Systems". A closed thoracic drainage system (chest drain and catheter together) are used to restore the chest to a more normalized condition after surgery, trauma, or spontaneous need for air and/or fluid to be removed. The Auto transfusion (ATS) features of the drains facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.
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    K Number
    K151386
    Device Name
    C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Date Cleared
    2015-10-22

    (149 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRIUM MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    C-QUR Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.
    Device Description
    C-QURTM Mesh is a sterile, knitted polypropylene monofilament mesh material for tissue reinforcement with a bio-absorbable, animal derived oil coating (O3FA) composed of fatty acids, lipids and glycerides. The C-QUR Mesh family is available in various configurations with sizes up to 12" X 18". The devices are terminally sterilized using Ethylene Oxide and intended as a single use device.
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    K Number
    K151437
    Device Name
    ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Date Cleared
    2015-08-27

    (90 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRIUM MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProLite Mesh and ProLite Ultra Mesh are intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds, and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material. ProLoop Mesh Plug is intended for use in soft tissue deficiencies including hernia repair and traumatic or surgical wounds requiring reinforcement with a non-absorbable supportive material.
    Device Description
    ProLite™ and ProLite Ultra™ Mesh are sterile, non-absorbable, knitted polypropylene monofilament mesh material. The ProLoop™ Mesh Plug is a non-absorbable, lightweight, pre-formed, three-dimensional plug constructed of knitted rows of monofilament polypropylene with multiple protruding monofilament loops. The devices are available in various configurations with sizes up to 12" X 18". The devices are terminally sterilized using Ethylene Oxide and intended as a single use device.
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    K Number
    K130142
    Device Name
    FLIXENE IFG VASCULAR GRAFT
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Date Cleared
    2013-03-15

    (52 days)

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

    ATRIUM MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atrium Flixene IFG Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
    Device Description
    Not Found
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    K Number
    K110110
    Device Name
    ATRIUM CENTRILFX MESH
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Date Cleared
    2011-02-15

    (32 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATRIUM MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Atrium CentriFX Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.
    Device Description
    Not Found
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