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The Visifiex Dual Lumen Catheter is intended for use during a two-guidewire procedure.

The Visifiex Dual Lumen Catheter is designed to allow for the insertion of two guidewires into a single vessel, preventing them from crossing or entangling, and then allowing them to separately advance into different vessels. The Visifiex Dual Lumen Catheter consists of two lumens: one lumen allows the guidewire to advance along its length, and the second lumen allows separation and release of the second guidewire via two skives located 35cm apart and peeling along its length. There is a radiopaque marker near the tip of the catheter to provide visibility when placing the Visifiex Dual Lumen Catheter. There is also a radiopaque marker located at the proximal skive to aid in positioning of the catheter for advancement of a guidewire. The Visifiex Dual Lumen Catheter has an orientation feature that provides for proper positioning to aid in guidewire placement. The Visifiex Dual Lumen Catheter has a working length of 90cm and is compatible with a 9Fr introducer sheath. The proximal end of the catheter consists of a female luer connector.

This document does not contain information about acceptance criteria, device performance, a study, or AI/algorithm-specific details. It is a 510(k) summary for a medical device (Visiflex Dual Lumen Catheter) and the FDA's clearance letter.

Therefore, I cannot populate the table or answer the questions as requested, as the provided text relates to regulatory clearance of a physical medical device and not a digital health product with performance metrics from a study.

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