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The ZigiWire Guidewire Systems facilitate placement and exchange of catheters and other instruments in the peripheral vasculature. The ZigiWire Guidewire Systems are not intended for use in the coronary arteries or neurovasculature.

The Vadiswire ZigiWire Mode2 and ZigiWire Mode3 Guidewire Systems are sterile guidewire systems designed to facilitate the placement of diagnostic catheters and sheaths in the peripheral vasculature. The individual guidewires used in the ZigiWire Systems consist of exchange length peripheral guidewires cleared under AdvanceCath (TechDevice) Corporation's 510(k) K053251. TechDevice Corporation manufactures the guidewires used in the ZigiWire Systems for Vadiswire, which are individually the same as several of the guidewires previously cleared under K053251. The ZigiWire Systems consist of two models: one (ZigiWire Mode3) incorporates three individual exchange length peripheral guidewires, and the second (ZigiWire Mode2) incorporating two individual exchange length peripheral guidewires. The individual guidewires used in the system range from 0.014 - 0.022 inches in diameter and are standard Teflon-coated, stainless steel guidewires with flexible radiopaque tips. Each ZigiWire System is provided with the individual guidewires in an all straight tip shape, or with all guidewires in the J-tip shape. The ZigiWire Systems are also provided with accessories which are intended to assist in inserting the guidewires into diagnostic catheters. These accessories consist of a wire introducer, which loosely holds the individual guidewires and helps to guide them into the hub of a catheter, a handle to separate the wires prior to use, and wire torquers for each wire. The handle incorporates a side port to enable flushing the introducer with the guidewires in place.