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510(k) Data Aggregation

    K Number
    K151513
    Device Name
    Arrow Endurance Extended Dwell Peripheral Catheter System
    Manufacturer
    Arrow Internation, Inc. (subsidiary of Teleflex Inc.)
    Date Cleared
    2015-07-08

    (34 days)

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

    Arrow Internation, Inc. (subsidiary of Teleflex Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARROW Endurance catheter system permits access to the patient's peripheral vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries.
    Device Description
    The Arrow® Endurance™ Extended Dwell Peripheral Catheter System is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The insertion device consists of an ergonomically designed handle with an integral echogenic needle with a passively-activated needle protection mechanism, guide wire with slider advancer, catheter release tab, and single-lumen catheter is advanced over the needle and threaded over a guide wire into a peripheral vessel. Throughout catheter insertion, blood is contained within the device to aid in prevention of blood exposure. The catheter system consists of a translucent radiopaque polyurethane catheter, a needle with openings to enhance flashback visibility, a seal in the catheter hub designed to reduce blood exposure, a stabilization platform with a strain relief nose designed to reduce kinking at the hub of the catheter, integrated extension tubing with Luer hub. vent plug to prevent blood from leaking out during insertion, and a clamp to eliminate blood exposure when the vent plug is removed and replaced with a mating Luer component such as an infusion set or Luer access device. The catheter is intended for short-term use (less than 30 days) to permit delivery of infusion therapies, infusion of blood products, pressure monitoring, high pressure injection at a maximum of 325 psi, and withdrawal of blood. The Arrow Endurance™ Extended Dwell Peripheral Catheter System is available in single lumen, 20 gauge configurations with usable lengths of 6 cm (2.36") and 8 cm (3.15").
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