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The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native peripheral arteries with total occlusions. The device is not to be used in the carotid arteries.

The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following: - 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (275cm Working Length) - 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (175cm Working Length) - 0.018" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (275cm Working Length) - 0.035" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) ◆ (275cm Working Length) - Safe-Cross RF System Console with Display and Footswitch . The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The The modified Bate-Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connector is connected to the OCR input on the console to allow the medical practitioner to visualize structures within the mible on the console to anow and more connector is connected to the RF output on the vessel for navigation purposes. al practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel. The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray with the Tip Shaping Tool. A Torquer is provided in a separate peel pouch. The packaged RF Crossing Wire is provided "STERILE" (ethylene oxide) and non-pyrogenic, and is intended for single use only.

The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native coronary arteries with total occlusions.

The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following: - 175cm Working Length 0.014" Safe-Cross RF Crossing Wire Straight and . Angled Tip (with Torquer and Tip Shaping Tool) - 275cm Working Length 0.014" Safe-Cross RF Crossing Wire Straight and . Angled Tip (with Torquer and Tip Shaping Tool) - Safe-Cross RF System Console with Display and Footswitch ● The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The proximal end of the RF Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR input on the console to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF output on the console. This allows the medical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel. The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray with the Tip Shaping Tool. A Torquer is provided in a separate peel pouch. The packaged RF Crossing Wire is provided "STERILE" (ethylene oxide) and non-pyrogenic, and is intended for single use only.

The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in vascular interventions in native peripheral arteries with total occlusions. The device is not to be used in the carotid arteries.

The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following: - 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (275cm Working Length) - 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (175cm Working Length) - 0.018" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) (275cm Working Length) - 0.035" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) . (275cm Working Length) - Safe-Cross RF System Console with Display and Footswitch . The proximal end of the RF Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR input on the console to allow the medical practitioner to visualize structures within OCK mpat on the connector is alles. The RF connector is connected to the RF output on the vessol of havigation practical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel. The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray with the Tip Shaping The Ice orosing 'Are wided in a separate peel pouch. The packaged RF Crossing Wire 1 on. 71 Torquer is provided oxide) and non-pyrogenic, and is intended for single use only.

The ILT Safe-Cross® Deflecting Catheter is indicated to be used in conjunction with a steerable guide wire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guide wire for another can occur. The Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The 0.018" Safe-Cross Deflecting Catheter is a coaxial lumen intravascular catheter coated with a Biocoat Hydak® hydrophilic coating intended for percutaneous use. It is designed to be used in conjunction with guide wires to gain access to and facilitate placement of the wires in locations within the vascular system that are remote from the site of insertion. Once accessed, guide wires may be exchanged within the catheter. The Safe-Cross® Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The effective length of the 0.018" Safe-Cross Deflecting Catheter is 135cm. The shaft deflecting segment maximum outside diameter is 4.3Fr at a use pressure of 10atm. The I.D. at the tip of the Safe-Cross Deflecting Catheter is a nominal 0.022" and the inside diameter will accommodate commercially available 0.018" guidewires. The 0.018" Safe-Cross Deflecting Catheter is packaged in a Tyvek® covered custom PETG tray that is heat-sealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE", "Non-Pyrogenic" and is intended for single use only.

The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native coronary arteries with total occlusions.

The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following: - 175cm Working Length 0.014" Safe-Cross RF Crossing Wirc Straight and . Angled Tip (with Torquer and Tip Shaping Tool) - 275cm Working Length 0.014" Safe-Cross RF Crossing Wire Straight and . Angled Tip (with Torquer and Tip Shaping Tool) - Safe-Cross RF System Console with Display and Footswitch . The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The I he modified Sale-Cross RF Bystein is simmal nt a Y-Site hub that houses the optic proximal end of the RF connector. The optical connector is connector is connected to the OCR input on the console to allow the medical practitioner to visualize structures within the imput on the console to anow the medical proceed to the RF couput on the digit vessel for havigation purposes. The re-over to provide discrete RF energy to the distal console: - This anoving the wire tip through the occlusion in the vessel. The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray with the Tip Shaping The Kr Crossing Wire is packaged warate peel pouch. A rorquer is provided the oxide) and non-pyrogenic, and is intended for single use only.

The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in vascular interventions of total occlusions in native iliac and superficial femoral arteries (SFA) of the lower extremities.

The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following: - 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) - 0.018" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer . and Tip Shaping Tool) - 0.035'' Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) . - Safe-Cross Console with Display and Footswitch . The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The proximal end of the RF Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR inout on the console to allow the medical practitioner to visualize structures within the wessel for navigation purposes. The RF connector is connected to the RF output on the console. This allows the medical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel. The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray with the Tip Shaping Tool. A Torquer is provided in a separate peel pouch. The packaged RF Crossing Wire is provided "STERILE" (ethylene oxide) and non-pyrogenic, and is intended for single use only.

The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in percutaneous interventions in native coronary arteries with total occlusions.

The Safe-Cross™ Radio Frequency (RF) Total Occlusion (TO) Crossing System consists of a the following: - 0.014" Safe-Cross RF Crossing Wire -- Straight and Angled Tip (with Torquer) . - Safe-Steer™ Optical Coherence Reflectometry (OCR) Unit with . Display Monitor - Safe-Cross RF Generator with Footswitch and Interface Cable . The Safe-Cross RF Crossing Wire is similar to the prodicate guidewire in construction and intended use. The proximal end of the Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR Unit to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF Generator. This allows the medical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel. The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray. The packaged RF Crossing Wire is sterilized by ethylene oxide gas. The packaged RF Crossing Wire is provided "STERILE" and Non-pyrogenic, and is intended for single use only.

The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in vascular interventions of total occlusions in native iliac and superficial femoral arteries (SFA) of the lower extremities.

The Safe-Cross Radio Frequency Total Occlusion Crossing System consists of the following: - 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) . - 0.035" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) . - Safe-Cross RF System Console . The modified Safe-Cross RF System is similar to the predicate Safe-Cross System. The proximal end of the Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR input on the console to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF output on the console. This allows the medical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel. The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray. The packaged RF Crossing Wire is provided "STERILE" (ethylene oxide) and non-pyrogenic, and is intended for single use only.

The Safe-Cross® Radio Frequency Total Occlusion Crossing System is indicated for use in facilitating the placement of devices used in vascular interventions of total occlusions in native iliac and superficial femoral arteries (SFA) of the lower extremities.

The Safe-Cross™ Radio Frequency (RF) Total Occlusion (TO) Crossing System consists of a the following: - 0.014" Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) ● - 0.035'' Safe-Cross RF Crossing Wire Straight and Angled Tip (with Torquer) . - Safe-Steer™ Optical Coherence Reflectometry (OCR) Unit with . Display Monitor - Safe-Cross RF Generator with Footswitch and Interface Cable . The Safe-Cross RF Crossing Wires are similar to the predicate guidewires in construction and intended use. The proximal end of the Crossing Wire is connected to a Y-Site hub that houses the optic fiber connector and the RF connector. The optical connector is connected to the OCR Unit to allow the medical practitioner to visualize structures within the vessel for navigation purposes. The RF connector is connected to the RF Generator. This allows the medical practitioner to provide discrete RF energy to the distal tip to assist in moving the wire tip through the occlusion in the vessel. The RF Crossing Wire is packaged in a Tyvek® sealed plastic tray. The packaged RF Crossing Wire is sterilized by ethylene oxide gas. The packaged RF Crossing Wire is provided "STERILE" and Non-pyrogenic, and is intended for single use only.

The Safe-Cross® Deflecting Catheter is indicated to be used in conjunction with a steerable guidewire in order to access discrete regions of the vasculature. Once the region has been accessed, an exchange of one guidewire for another can occur. The Safe-Cross® Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

The Safe-Cross Deflecting Catheter is a coaxial lumen intravascular catheter coated with a Biocoat Hydak® hydrophilic coating intended for percutaneous use. It is designed to be used in conjunction with guidewires to gain access to and facilitate placement of the wires in locations within the vascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. The Safe-Cross Deflecting Catheter may also be used to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The effective length of the Safe-Cross Deflecting Catheter is 135-140 cm. The shaft nominal outside diameter is 2.5 F (0.033") and the maximum outside diameter of the deflecting segment is 3.5 F (0.045") at a use pressure of 10 atm. The I.D. at the tip of the Safe-Cross Deflecting Catheter is a nominal 0.016" and the inside diameter will accommodate commercially available 0.014" guidewires. The Safe-Cross Deflecting Catheter is packaged in a Tyvek® covered custom PETG tray that is heat-sealed to form a sterile barrier. The packaged units are sterilized with ethylene oxide gas. The device is provided "STERILE". "Non-Pyrogenic" and is intended for single use only.