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    K Number
    K111426
    Device Name
    EUCLID (TM) TIER 1-GW ACCESS SYSTEM
    Manufacturer
    HOUSTON MEDICAL ROBOTICS
    Date Cleared
    2012-03-01

    (283 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOUSTON MEDICAL ROBOTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Euclid™ Tier 1 Mini Access System is used to facilitate the placing of a needle and guidewire into a targeted anatomical location.
    Device Description
    The Euclid™ Tier 1 Mini Access System is designed to provide the medical practitioner with the capability to accurately and reliably insert a guidewire into a vessel. The device consists of (1) the Euclid™ Tier 1 Mini Base Kit containing the sterile disposable device assembly consisting of a needle (18/21 Gauge) and guidewire (0.18" diameter x 40 cm length), a Euclid™ Ultrasound Imaging Screen Overlay, and IFU; and (2) the Euclid™ Tier 1 Mini Transducer Adapter Kit which contains a Euclid™ Transducer Adapter and IFU.
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