Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213855
    Device Name
    Arrow Pressure Injectable Midline Catheter
    Manufacturer
    Arrow International LLC Subsidiary of Teleflex Incorporated
    Date Cleared
    2022-09-02

    (266 days)

    Product Code
    PND
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Arrow International LLC Subsidiary of Teleflex Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arrow(R) Pressure Injectable Midline Catheter is indicated for short-term (≤ 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
    Device Description
    The Arrow Pressure Injectable Midline Catheter is a non-coated, single use catheter designed to provide short-term peripheral access to the venous system. The midline catheter is a peripherally inserted intravenous catheter manufactured with medical grade, flexible polyurethane. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a single opening or double opening at the distal end and centimeter markings placed along its length to facilitate its positioning. The catheter is available in 4 Fr. Single lumen and 5 Fr. Double lumen configurations with a usable catheter length of 20 cm. Pinch clamps are an integral part of the catheter and are provided on the extension lines to occlude flow through the lumens, as needed. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec. The catheters will be packaged sterile in kits that will include components to facilitate insertion.
    Ask a Question

    Page 1 of 1