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The Phoenix Atherectomy System is in atherectomy of the peripheral vasculature. The system is not intended for use in the coronary, carotid, iliac, or renal vasculature.

The Phoenix Atherectomy System is a sterile, single-use device designed for atherectomy of the peripheral vasculature. The Phoenix Atherectomy System has two main components: the Phoenix Catheter and the Phoenix Handle. The Phoenix Catheter is a flexible, over-the-wire (OTW), front-cutting Catheter that continuously captures and clears debulked plaque proximally through the Catheter and Handle into a collection reservoir that resides outside the patient. For use, the Phoenix Catheter is inserted into the Phoenix Handle. The Handle incorporates a self-contained battery-powered motor designed to drive and rotate the cutter of the Phoenix Atherectomy Catheter at its specified rotational speed. The device is activated by an ON/OFF slider switch on the top of the Handle. A Wire Support Clip is used to hold the guidewire in a fixed position relative to the Handle and prevent guidewire rotation during the procedure. The Catheter, Handle, and Wire Support Clip are packaged as sterile, single-use components of the Phoenix Atherectomy System. There are multiple models of the Phoenix Catheter. The Phoenix Tracking Catheter models track directly over the guidewire with no tip deflection capability. The currently marketed models available for clinical use are 1.8mm, 2.2mm, and 2.4mm tip diameter sizes. The controls for rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires, and all use the same Phoenix Handle. The subject 510(k) submission is proposed to introduce the following modifications: (i) the predicate 2.2 mm X 130cm Phoenix Deflecting Catheter is being modified to add a new model with a 2.4mm distal cutter assembly to enable debulking to a larger lumen diameter. The 2.4 mm distal cutter assembly is equivalent in design to the currently marketed 2.4mm X 127cm Phoenix Deflecting Catheter. (ii) the predicate 1.8 mm X 149cm Phoenix Tracking Catheter is being modified to add a 1.5mm tip diameter X 149cm Phoenix Tracking Catheter model to the Phoenix Catheter product family.

The Phoenix® Atherectomy System is in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Phoenix Atherectomy System is a sterile, single-use device designed for atherectomy of the peripheral vasculature. The Phoenix Atherectomy System has two main components: the Phoenix Catheter and the Phoenix Handle. The Phoenix Catheter is a flexible, over-the-wire (OTW), front-cutting Catheter that continuously captures and clears debulked plaque proximally through the Catheter and Handle into a collection reservoir that resides outside the patient. For use, the Phoenix Catheter is inserted into the Phoenix Handle incorporates a self-contained battery-powered motor designed to drive and rotate the cutter of the Phoenix Atherectomy Catheter at its specified rotational speed. The device is activated by an ON/OFF slider switch on the top of the Handle. An accessory, the Phoenix Wire Support Clip, is also supplied and can be used to clip a guidewire torque device in a fixed position relative to the Phoenix Handle. The Catheter, Handle, and Wire Support Clip are each packaged separately as sterile, single-use components of the Phoenix Atherectomy System. There are multiple models of the Phoenix Catheter. The smaller 1.8mm and 2.2mm Phoenix Catheter models are compatible with 5F and 6F sheaths, respectively, and track directly over the guidewire with no tip deflection capability. The larger 2.4mm Phoenix Catheter is 7F with the tip having deflection capability. All Phoenix Catheter models use the same Phoenix Handle and are compatible with specific commercially available 0.014" exchange length (260 cm or greater) guidewires listed in the product's instructions for use. This 510(k) includes modifications to the 2.4mm tip diameter Phoenix Deflecting Catheter distal cutter assembly, as well as the Catheter and proximal chassis design to optimize the ease of use, tip deflection capabilities and manufacturability of the device. Table 9-1 summarizes the subject modifications relative to the predicate devices.

The Phoenix® Atherectomy System is in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Phoenix Atherectomy System is a sterile, single-use device designed for atherectomy of the peripheral vasculature. The Phoenix Atherectomy System has two main components: the Phoenix Catheter and the Phoenix Handle. The Phoenix Catheter is a flexible, over-the-wire (OTW), front-cutting Catheter that continuously captures and clears debulked plaque proximally through the Catheter and Handle into a collection reservoir that resides outside the patient. For use, the Phoenix Catheter is inserted into the Phoenix Handle incorporates a self-contained battery-powered motor designed to drive and rotate the cutter of the Phoenix Atherectomy Catheter at its specified rotational speed. The device is activated by an ON/OFF slider switch on the top of the Handle. An optional Wire Support Clip can also be used to clip a guidewire torque device in a fixed position relative to the Handle. The Catheter, Handle, and Wire Support Clip are each packaged separately as sterile, single-use components of the Phoenix Atherectomy System. There are multiple models of the Phoenix Catheter. The smaller Phoenix Catheter models track directly over the guidewire with no tip deflection capability. These models are available in 1.8 mm and 2.2 mm tip diameter sizes. The controls for rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires, and all use the same Phoenix Handle. This 510(k) includes modifications to the 1.8 mm and 2.2 mm tip diameter Phoenix Catheter models to increase the overall working length from 130 cm to 149 cm and thereby create two new longer-length models within the Phoenix Catheter product family.