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The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse / deliver diagnostic and therapeutic agents.

The ViperCross™ Support Catheters are single lumen catheters designed for use in the peripheral vasculature. The ViperCross™ Support Catheters provide guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The ViperCross support catheters have a hydrophilic coating on the distal 30cm, 40cm, 70cm, or 90cm dependent on model length to enhance deliverability to the target vasculature. The ViperCross™ Support Catheters have three (3) radiopaque marker bands located 0.040" / 1.01mm, 1.968" / 50mm, and 3.937" / 100mm from the distal tip, respectively. The 135cm and 150cm catheters have white positioning marks located at 100cm and 110cm from the distal tip. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing. The 014 or 018 ViperCross™ Support Catheter can be placed through the 035 ViperCross™ Support Catheter for extended reach and pushability. The ViperCross™ Support Catheters have been sterilized with ethylene oxide.

0.014" The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse/deliver diagnostic and therapeutic agents. 0.018" & 0.035" The ViperCross™ Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to sub-selectively infuse / deliver diagnostic and therapeutic agents.

014: The ViperCross™ Support Catheter is a single lumen catheter designed for use in the peripheral and/or coronary vasculature. The ViperCross™ Support Catheter provides guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The ViperCross™ Support Catheters have a hydrophilic coating on the distal 90cm or 70cm dependent on model length to enhance deliverability to the target vasculature. The ViperCross™ Support Catheters have a single radiopaque marker band located 0.040" / 1.02mm from the distal tip. The catheters have white positioning marks located at 100cm and 110cm from the distal tip. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing. 018/035: The ViperCross™ Support Catheter is a single lumen catheter designed for use in the peripheral vasculature. The ViperCross™ Support Catheter provides guidewire support during interventional procedures and allows for the exchange of one distally located guidewire for another while maintaining access to distal vasculature. The ViperCross™ Support Catheters have a hydrophilic coating on the distal 90cm, 70cm, or 40cm dependent on model length to enhance deliverability to the target vasculature. The ViperCross™ Support Catheters have a single radiopaque marker band located 0.040" / 1.02mm from the distal tip. The 135cm catheters have white positioning marks located at 100cm and 110cm from the distal tip. The proximal end of the catheter incorporates a strain relief and a luer-lock adapter for flushing. The ViperCross™ Support Catheters have been sterilized with ethylene oxide.

The ViperCath™ XC Peripheral Exchange Catheter is intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges, and provide a conduit for the delivery of saline or diagnostic contrast agents.

The ViperCath XC Exchange Catheter is intended to be used to facilitate vascular access and guidewire exchanges during peripheral vascular intervention procedures. It is available in the following lengths with a straight tip: 65, 90, 135, and 150 cm as described in this submission. A 200 cm length is also available and was previously cleared under K183000 with a straight tip and an angled tip. There are no accessories for this device. The catheter is compatible with .035" guidewires and has radiopaque marker bands at distances of 1 cm and 5 cm from the distal tip. The ViperCath XC is supplied sterile with one catheter per box.

The ViperCath XC Peripheral Exchange Catheter is intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

The ViperCath XC Exchange Catheter (ViperCath XC) is intended to be used to facilitate vascular access and guidewire exchanges during peripheral vascular intervention procedures. It is provided in a 200 cm length, to facilitate the radial access approach, with either a straight or angled tip. There are no accessories for this device. The catheter shaft has radiopaque marker bands at distances of 1 cm and 5 cm from the distal tip. Two additional printed markers are located 120 cm and 150 cm from the distal tip and are provided to aid with placement.

The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis. The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Diamondback 360 uses an eccentrically orbiting sanding surface (crown) to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body. The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components: 1) Orbital Atherectomy Device (OAD) 2) Atherectomy Guide Wire (e.g., ViperWire Advance) 3) Saline Pump (OAS Pump) 4) Atherectomy Lubricant (e.g., ViperSlide) Additional 1.25 Solid, 1.50 Solid, and 1.75 Solid Diamondback 360 Peripheral Orbital Atherectomy Devices (OADs) with increased drive shaft lengths of 180 cm and 200 cm are proposed as additional length options to accommodate patient vessel anatomy and physicians preferred access methodology, for example radial access. The proposed OADs are designed to maintain 5Fr compatibility. Additional accessories to accommodate the increased drive shaft lengths were necessitated such as additional saline sheaths with increased lengths and additional lengths of ViperWire Advance Peripheral guide wires to accommodate the working length of the proposed OADs. The proposed 0.014 in core guide wires are 475 cm in length and compatible with the 180 cm and 200 cm length drive shafts. The proposed 0.014 in core guide wires are designed with a 0.014 in or 0.018 in distal spring tip options. The proposed dimensions of the 1.75 Solid crown are configured to accommodate the smaller diameter drive shaft while maintaining 5Fr compatibility. Packaging dimensions were increased in comparison to that of the predicate packaging to accommodate for the increased OAD and guide wire lengths.

The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis. The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Diamondback 360 uses an eccentrically rotating sanding surface (crown) to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body. The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components: - 1) Orbital Atherectomy Device (OAD) - 2) Atherectomy Guide Wire (e.g., ViperWire Advance) - 3) Saline Infusion Pump (SIP) - 4) Atherectomy Lubricant (e.g., ViperSlide)

The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis. The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Diamondback 360 uses an eccentrically rotating sanding surface (crown) to remove stenotic material on the vessel wall. The stenotic particles that are removed are small enough to be absorbed by the body. The Diamondback 360 Peripheral Orbital Atherectomy System consists of the following components: - 1) Orbital Atherectomy Device (OAD) - 2) Atherectomy Guide Wire (e.g., ViperWire Advance) - 3) Saline Infusion Pump (SIP) - 4) Atherectomy Lubricant (e.g., ViperSlide)

The Stealth 360° Orbital PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectorny system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Stealth 360° Orbital PAD System is an orbital atherectomy system (OAS) that is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis. The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Stealth 360° uses an electrically driven shaft to apply a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body. The Stealth 360° Orbital PAD System consists of the following components: - 1) Orbital atherectomy device (OAD) - 2) Atherectomy guide wire - 3) Externally operated saline pump - 4) Atherectomy Lubricant (e.g. ViperSlide)

The Diamondback 360° Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Diamondback 360° Orbital Atherectomy System with ViperSlide is an orbital atherectomy system (OAS) that is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis. The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The OAS applies a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body. The Diamondback 360° Orbital Atherectomy System consists of the following components: - 1) Orbital atherectomy device (OAD, air or electric powered) - 2) Atherectomy guide wire - 3) Atherectomy saline pump or controller - 4) Atherectomy lubricant

The Stealth 360° Orbital PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

The Stealth 360™ Orbital PAD System is an orbital atherectomy system (OAS) that is intended for use in the treatment of peripheral arteries and A-V graft (shunt) stenosis. The OAS provides a method of removing stenotic material from peripheral arteries and A-V grafts. The Stealth 360° uses an electrically driven shaft to apply a diamond coated, eccentrically rotating surface to ablate stenotic material. The stenotic particles that are removed are small enough to be absorbed by the body. The Stealth 360° Orbital PAD System consists of the following components: - 1) Orbital atherectomy device - 2) Atherectomy guide wire - 3) Externally operated saline pump - 4) Atherectomy Lubricant (e.g. ViperSlide)