Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K231218
    Device Name
    Distal Access Catheter
    Manufacturer
    AccuMedical Beijing Ltd.
    Date Cleared
    2024-01-19

    (266 days)

    Product Code
    QJP, DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    AccuMedical Beijing Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.
    Device Description
    The Distal Access Catheter is a single lumen, flexible, variable stiffness composite catheter which has a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The Distal Access Catheter has a radiopaque marker on the distal tip that is visible under fluoroscopy. The Distal Access Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The catheter has a straight tip. The catheter is offered in various lengths to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.
    Ask a Question

    Page 1 of 1