LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K024165
    Device Name
    DUAL-LUMEN CATHETER
    Manufacturer
    BISTECH, INC.
    Date Cleared
    2003-01-10

    (24 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    BISTECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use with a bronchoscope to deliver fluids to or withdraw fluids from the lung.
    Device Description
    The proposed device consists of a two-lumen catheter with proximal bifurcation and luer hubs. The device will be supplied with a removable stylette in one of the lumens that is intended to provide support and prevent kinking as the catheter is inserted through the working channel of a bronchoscope.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1