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510(k) Data Aggregation

    K Number
    K241451
    Device Name
    Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric)
    Manufacturer
    Teleflex Incorporated
    Date Cleared
    2025-02-11

    (265 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    Teleflex Incorporated

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Reinforced Tube: Rusch Reinforced Endotracheal Tubes are designed for nasal intubation and are indicated for airway management. The correct designation (oral, nasal or oral/nasal) is printed on the tube and unit package. Reinforced Endotracheal Tubes may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation. The Reinforced Endotrached to be used on all patients requiring ventilation, pediatric and adult. Safety Clear and Safety Clear Pediatric Tubes: Rusch Endotracheal Tubes, Cuffed and Uncuffed, with or without Murphy Eye are for oral or nasal intubation. They are indicated for airway management. The Rusch Endotracheal Tubes are intended to be used on all patients requiring ventilation, pediatric and adult.
    Device Description
    An endotracheal tube is a device that is inserted into the trachea via the nose or the mouth to establish a patent airway to allow ventilation. The proposed Teleflex Medical Rusch Endotracheal Tubes are sterile, single use devices that are made non made with DEHP. The tracheal tubes contain a compatible cuff, inflation line, pilot balloon and one-way valve. A radiopaque line is incorporated into the full length of the Safety Clear tracheal tube, while the Reinforced tube contains an embedded stainless-steel spiral that allows for X-ray visualization. Each tracheal tube is supplied with an appropriately sized 15mm connector.
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    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.
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