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510(k) Data Aggregation

    K Number
    K032660
    Device Name
    XTRAK SUPPORT CATHETER
    Manufacturer
    XTRAK MEDICAL INC.
    Date Cleared
    2003-10-29

    (62 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    XTRAK MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Xtrak Support catheter is intended to be used in conjunction with a steerable guidewire in order to access discreet regions of the vasculature.
    Device Description
    The Xtrak Support catheter shaft consists of a flexible, distal section made of closely-wound coils, and a stiffer and more torqueable mid-section coupled to a proximal handle through a short length of spiraled strain relief. The distal and mid-shaft sections, and the strain relief are constructed from a continuous length of stainless steel wire to maximize catheter integrity. The catheter is provided in various sizes to accommodate .014" and .018" quidewires.
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    K Number
    K021641
    Device Name
    XTD THROMBECTOMY CATHETER, XX CM
    Manufacturer
    XTRAK MEDICAL INC.
    Date Cleared
    2002-07-26

    (67 days)

    Product Code
    QEW, DXE
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    XTRAK MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For breaking apart and removing thrombus from hemodialysis access grafts.
    Device Description
    The XTD™ Thrombectomy Catheter is a sterile, single-use, disposable catheter designed to simultaneously fragment and remove thrombus from clotted hemodialysis access grafts. The catheter consists of a flexible, spiral-conveyor shaft rotating within a plastic sheath. The shaft has a small, flexible, curved agitator which extends out of the sheath. As the agitator rotates it breaks the thrombus to particles are aspirated into the sheath and are conveyed by the rotating spiral shaft through the sheath to a collection line connected to a disposable vacuum syringe. A pinch clamp on the collection line isolates the svringe and allows the operator to manually control the delivery of suction to the catheter tip. The battery supply and a luer connection for the syringe are incorporated directly onto the catheter.
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    K Number
    K013473
    Device Name
    XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL
    Manufacturer
    XTRAK MEDICAL INC.
    Date Cleared
    2002-03-06

    (139 days)

    Product Code
    MCW
    Regulation Number
    870.4875
    Why did this record match?
    Applicant Name (Manufacturer) :

    XTRAK MEDICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For breaking apart and removing thrombus from hemodialysis access grafts.
    Device Description
    The XTD™ Thrombectomy System consists of the XTD™ Thrombectomy Catheter has a flexible, rotating spiral conveyor shaft contained within a plastic sheath, a Control Console, and a disposable Collection Bottle. As the agitator rotates it macerated thrombus within the graft and the rotating spiral conveyor shaft conveys the macerated thrombus through the sheath, assisted by negative pressure, to a disposable Collection Bottle. The Control Console provides power and control of the catheter operation.
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