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This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The VASSALLO® GT Crossing14 Peripheral Guide Wire in this submission is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) in available lengths of 190cm and 300cm. The outer coil wire diameter has been modified to 0.072 mm. The devices have a solid core with a hvdrophilic coated coil-type distal end. The coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2 cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the quide wire with a length of less than 300cm. A Torque device is included in the same package.

This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The VASSALLO® GT 018 G12 and G30 Peripheral Guide Wires in this submission are a steerable guide wire with a maximum diameter of 0.018 inches (0.45mm) in available lengths of 190cm and 300cm. The devices have a solid core with a hydrophilic coated coil-type distal end. The entire coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2 cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the guide wire with a length of less than 300 cm. A Torque device is included in the same package.