Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K030400
    Device Name
    NEOSCI MEDICAL ENDOLUMINAL BRUSH
    Date Cleared
    2004-12-22

    (685 days)

    Product Code
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEOSCI MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NeoSci Medical Endoluminal Brush is intended to collect a sample, which is suitable for microbiological analysis, from the inner lumen surface of an indwelling central venous catheter. The proximal nitinol shaft is encased in a polytetrafluoroethylene sheath with a hydrophilic coating applied to reduce friction. The device is contraindicated for patients with known, or suspected, allergies to nitinol, PTFE Teflon®, Nylon, stainless steel, gold, or hydrophilic coatings.
    Device Description
    The NeoSci Medical (NSM) Endoluminal Brush (EB) is a device similar to a very small diameter bottlebrush that can be inserted into the lumen of partially obstructed central venous catheters to collect a sample. The distal end of the device consists of a flexible tip equivalent to that of a floppy guide wire tip. Immediately proximal to the flexible tip is a segment of bristles wound into flexible. twisted (braided) stainless steel wires. The outer diameter of the bristle is selected by the user. Instructions for use recommend that the EB size be 1.2 to 2.0 times the inner diameter of the lumen to be sampled. The stainless steel wires are bonded to a nitinol shaft that extends to the proximal end of the device. The proximal nitinol shaft is encased in a polvtetrafluoroethylene sheath with a hydrophhilic coating applied to reduce friction.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1