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510(k) Data Aggregation

    K Number
    K021196
    Device Name
    NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735
    Date Cleared
    2002-07-01

    (76 days)

    Product Code
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEURON THERAPEUTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Neuron Therapeutics Inc., 14-Gauge Lumbar Puncture Set is indicated for temporary access to the lumbar subarachnoid region to drain cerebrospinal fluid (CSF) and other fluids of similar physical characteristics.
    Device Description
    The Neuron Therapeutics 14-Gauge Lumbar Puncture Set, part number PN1000735, consists of a 14-Gauge Lumbar Catheter Kit, a Transparent Tegaderm™ Dressing, a Suture-less Catheter Anchor, and a Sterile Drape. These individual, sterile packaged components are provided in sealed tamper-evident packaging for single-use. The 14-Gauge Lumbar Catheter Kit, part number PN1000737, contains a single 30 cm coiled lumbar catheter with an inner diameter of 1.25 mm, an outer diameter of 1.74 mm and 35 fenestrations. The shorter length, larger diameter and higher number of fenestrations of the catheter allow for decreased flow resistance and higher liquid flow rates. The higher number of fenestrations decreases the possibility of occlusion of the catheter during use. The catheter is constructed of polyurethane to provide resistance to kinking or collapsing. The catheter has 13 location markings positioned at 1 cm intervals to assist the physician in identifying the location of the distal end of the catheter in the subarachnoid space. Special markings are provided to indicate the location of the catheter tip, the proximal fenestration and the coiled shaft as they exit from the needle tip. The 14-Gauge Lumbar Catheter Kit also contains a 15.0 cm, 14-gauge Extra-Thin Wall Touhy Needle and a 45 cm stainless steel flexible J-tip guidewire for inserting and guiding the catheter into the lumbar subarachnoid space. A 6-French Touhy-Borst Connector is also included for connection to equipment for patient monitoring or fluid collection.
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