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510(k) Data Aggregation

    K Number
    K080603
    Device Name
    HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
    Manufacturer
    Date Cleared
    2008-08-05

    (155 days)

    Product Code
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    TE ME NA SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Temena Nerve Location Needles are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves with a nerve stimulator and/or with an ultrasound device.
    Device Description
    The Temena Hybrid and USC Nerve Location Needles include a stainless steel cannula and connections for anesthetic administration and with the Hybrid Needle a connection for nerve stimulation. The needle is available in a range of lengths and 21 or 22 AWG. The USC (uncoated version) may be used for echo nerve location and the Hybrid (coated version) for both stimulator and echo location.
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    K Number
    K060186
    Device Name
    POLYPLEX STIMULATING CATHETER SYSTEM
    Manufacturer
    Date Cleared
    2006-07-18

    (175 days)

    Product Code
    Regulation Number
    868.5140
    Why did this record match?
    Applicant Name (Manufacturer) :

    TE ME NA SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Te me na POLYPLEX Stimulating Catheter System is intended for placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
    Device Description
    The Polyplex Stimulating Catheter System is an anesthesia conduction catheter that is electrically conductive. Using peripheral nerve stimulation, the clinician can locate specific nerves or nerve plexuses for continuous nerve block anesthesia or analgesia. The Polyplex Stimulating Catheter System is available sterile in a kit with the necessary accessories required to perform the procedure and fix the catheter in place.
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