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The Nexus TKO®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure anti-reflux device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients.

The Nexus TKO®6P may also be safely used with power injectors at 10mL/sec and pressures up to 325 psi.

The Nexus TKO®-6P incorporates anti-reflux technology which prevents blood reflux resulting from the following conditions: bag run-dry, connection and disconnection of luer lock devices, syringe plunger compression and patient vascular changes, such as coughing or sneezing.

The Nexus TKO®-6P has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (Nexus TKO®-6P, Luer Activated Device), which describes the device's indications for use and regulatory classification. However, it does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or other study-related information.

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