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510(k) Data Aggregation

    K Number
    K111064
    Device Name
    TIGERPAW SYSTEM II
    Manufacturer
    LAAX, INC.
    Date Cleared
    2011-05-18

    (30 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAAX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TigerPaw® System II is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
    Device Description
    The TigerPaw® System II consists of an implantable Fastener and Delivery Tool designed for occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. The Fastener is composed of linearly spaced connectors overmolded with a soft silicone. The spacing between the connectors along with the silicone gives the Fastener an ability to conform to the anatomy and exclude the LAA. The TigerPaw System II also includes a hand-held disposable Delivery Tool. The Delivery Tool consists of a pistol grip handle with two triggers that when separately actuated, close opposing jaws thus mating the two sides of the permanently implanted Fastener, and, then allowing release of the Fastener and opening of the jaws for Delivery Tool removal.
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    K Number
    K101961
    Device Name
    TIGERPAW SYSTEM
    Manufacturer
    LAAX, INC.
    Date Cleared
    2010-10-29

    (109 days)

    Product Code
    GDW, GOW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    LAAX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TigerPaw® System is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).
    Device Description
    The TigerPaw System consists of an implantable Fastener and Delivery Tool designed for occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. The Fastener is composed of linearly spaced connectors overmolded with a soft silicone. The spacing between the connectors along with the silicone gives the Fastener an ability to conform to the anatomy and completely exclude the LAA. The TigerPaw® System also includes a hand-held disposable Delivery Tool. The Delivery Tool consists of a pistol grip handle with triggers that when actuated close jaws that in turn mate the two sides of the permanently implanted Fastener together.
    Ask a Question

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