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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 (OAD) - 2) Atherectomy Guide Wire - 3) Saline Infusion Pump (SIP) - 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 Diamondback 360°™ Orbital Atherectomy System is also indicated for removal of stenotic material from artificial arteriovenous dialysis fistulae (A-V shunts).

The Diamondback 360°™ Orbital Atherectomy System (OAS) with Sidewinder Shaft is intended for use in the treatment of peripheral artery and A-V shunt stenosis. OAS provides a method of removing stenotic material from peripheral arteries and A-V shunts. OAS applies a diamond coated, eccentrically rotating cutting surface to ablate stenotic material. The resulting particles of removed stenotic material are very small and can be absorbed by the body. The Diamondback 360° Orbital Atherectomy System consists of the following three significant components: - 1) Orbital atherectomy device, with biased shaft - 2) Orbital atherectomy controller, and - 3) Atherectomy guidewire. This 510(k) is for the same device with modifications to the shaft configuration of the orbital atherectomy device for improved sanding efficiency.

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