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510(k) Data Aggregation

    K Number
    K041338
    Device Name
    MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES
    Manufacturer
    MEDTRONIC VASCULAR
    Date Cleared
    2004-07-19

    (60 days)

    Product Code
    MWS
    Regulation Number
    870.4500
    Why did this record match?
    Product Code :

    MWS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medtronic Octopus TE Stabilizer is used to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery. It is intended to be used by trained medical professionals in operating room environments. The Stabilizer is intended to stabilize the epicardial surface of the nonarrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments.
    Device Description
    The non-sterile, reusable Medtronic Octopus TE Heart Stabilizing System is a suction-based tissue stabilizer with a collapsible pod assembly, a rigid shaft and 5 articulating links designed to enable transfer into the thoracic cavity via a 12 mm thoracic port or traditional sternotomy access. It is comprised of four distinct elements: (1) the Medtronic Octopus TE Tissue Stabilizer, (2) the Medtronic Octopus TE Suction Lines, (3) the Medtronic Octopus TE Vacuum Lines, and (4) the Medtronic Octopus TE Irrigator (optional). The Medtronic Octopus TE Heart Stabilizer is secured to a flexible arm and universal mounting rail, which attached to the operating table rail. Vacuum is delivered to the pod assembly by a disposable suction line inserted through the shaft of the stabilizer and a disposable vacuum line that connects the stabilizer to the vacuum source. The accessories are sold separately.
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    K Number
    K992476
    Device Name
    PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
    Manufacturer
    PILLING WECK SURGICAL
    Date Cleared
    2000-09-13

    (415 days)

    Product Code
    MWS, MMS
    Regulation Number
    870.4500
    Why did this record match?
    Product Code :

    MWS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heart Stabilizer Pad is used on an appropriate heart stabilizer unit for coronary bypass surgery. It provides a mechanical means for immobilization of the anastomotic site on a beating heart and provides coronary artery isolation and occlusion by compression.
    Device Description
    Pilling Weck Surgical Stabilizer Removable Pads
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    K Number
    K992833
    Device Name
    VACUUM ASSIST STABILIZER
    Manufacturer
    CARDIO THORACIC SYSTEMS
    Date Cleared
    1999-11-10

    (79 days)

    Product Code
    MWS
    Regulation Number
    870.4500
    Why did this record match?
    Product Code :

    MWS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CTS Vacuum Assist Stabilizer is intended for use during the performance of minimally invasive cardiac surgery. Used in conjunction with the CTS Ultima™ OPCAB™ System, the stabilizer isolates and provides local immobilization of the target vessel on the beating heart.
    Device Description
    The CTS Vacuum Assist Stabilizer consists of a curved shaft with an articulating foot at the distal end and a mount that connects to the CTS AccessRail™ Platform. The stabilizer provides local immobilization of an anastomotic site.
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    K Number
    K982419
    Device Name
    HEART-LIFT BALLOON POSITIONER
    Manufacturer
    CARDIOTHORACIC SYSTEMS, INC.
    Date Cleared
    1999-01-13

    (184 days)

    Product Code
    MWS
    Regulation Number
    870.4500
    Why did this record match?
    Product Code :

    MWS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CTS Heart-LIFT Balloon Positioner is a surgical instrument intended to lift and position the heart during cardiac surgery.
    Device Description
    The CTS Heart-LIFT Balloon Positioner consists of a manually inflatable, latex-free balloon attached to a malleable shaft. The balloon is inflated using a hand pump, which is attached via a flexible air tube to the proximal end of the malleable shaft. A pressure release valve allows deflation of the balloon. There also is a pressure relief valve to prevent over-inflation.
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