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Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

The system consists of an introducer, a mini-guidewire, and a vessel dilator. The introducer consists of a cannula of co-extruded polyethylene with barium sulfate, a high density polyethylene body, and polyurethane sideport extension. The radiopaque tip is made of a blend of tungsten, polyethylene, and zinc stearate.
• 4 - 9 French
• 3 - 120 cm length
• .035" - 038′ mini guidewire

This document is a 510(k) premarket notification for the Cordis Brite Tip Catheter Sheath Introducer and does not contain information about acceptance criteria or a study proving the device meets them.

The document primarily focuses on demonstrating "substantial equivalence" to a predicate device, which is a regulatory pathway used when a new device is as safe and effective as an already legally marketed device. This pathway typically relies on demonstrating similar technological characteristics and intended use, rather than presenting a full study with acceptance criteria and performance metrics.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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