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510(k) Data Aggregation

    K Number
    K060967
    Device Name
    NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
    Manufacturer
    STEREOTAXIS, INC.
    Date Cleared
    2006-10-19

    (195 days)

    Product Code
    NDQ, NDO
    Regulation Number
    870.1290
    Why did this record match?
    Product Code :

    NDQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Niobe® MNS with Navigant™ NWS is intended to navigate a magnet-tipped device through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction.
    Device Description
    The Stereotaxis Niobe® MNS with Navigant™ NWS is an interventional workstation for the intravascular navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites. The system uses computer-controlled permanent magnets for orienting the tip of a magnetic device. It is important to note that the system employs magnetic fields only to orient or steer the tip of a magnetic device.
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    K Number
    K051373
    Device Name
    CRONUS GUIDEWIRE, MODEL 001-001470-1
    Manufacturer
    STEREOTAXIS, INC.
    Date Cleared
    2005-12-09

    (197 days)

    Product Code
    NDQ
    Regulation Number
    870.1290
    Why did this record match?
    Product Code :

    NDQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Telstar® Magnetic Navigation System [TMNS] is intended to navigate a magnetic-tipped device through tissue to designated target sites in the right and left heart, coronary, peripheral, and neurovasculature by orienting the device tip in a desired direction. The Stereotaxis Endovascular Guide Wire is intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the neurovasculature, coronary and peripheral vasculature during PTCA or other intravascular interventional procedures.
    Device Description
    The Telstar® Magnetic Navigation System [TMNS] is an interventional workstation for the intravascular navigation of a magnetic-tipped device through tissue to designated target sites in the right and left heart, coronary, peripheral, and neurovasculature. It combines a bi-planar fluoroscopy system with a computer controlled magnetic field generator, to provide both visualization and control of a magnetically actuated guidewire. The system employs magnetic fields to orient the guidewire. The Stereotaxis Cronus® Modified is a steerable guidewire that has a nominal diameter of 0.014 in/0.36 mm and a nominal length of 210 cm or 300 cm. The guidewire is designed only for use in conjunction with a Stereotaxis Telstar® Magnetic Navigation System [TMNS]. The wire is configured with a tapered distal tip and an embedded magnet, which is used for navigating the wire through the vasculature. This device is sterilized with 100% ethylene oxide.
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