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The Avanti™ Trans-Radial Catheter Sheath Introducer kit is intended for use in (radial) arterial procedures requiring percutaneous introduction of catheters and other intravascular devices.

As with other currently marketed Cordis CSIs mentioned in this submission, these devices provide vascular access for various intravascular devices through the valve while simultaneously maintaining hemostasis. Infusion of fluids into the vasculature and withdrawal of blood from the vasculature are possible using the sheath sideport.

This document is a 510(k) summary for a medical device (Cordis Avanti™ Trans-Radial Sheath Introducer Kit). It describes the device, its intended use, and its equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance metrics, or any study design that would prove the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The provided text is a regulatory submission focused on demonstrating substantial equivalence to existing devices, not a performance study report with specific acceptance criteria and results.

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