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The QuickClear Mechanical Thrombectomy System is intended for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

The QuickClear Mechanical Thrombectomy System is an aspiration thrombectomy system designed for removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems. The QuickClear Mechanical Thrombectomy System removes thrombus from the peripheral vasculature using continuous vacuum aspiration, through a single lumen aspiration catheter. The system components are sterile, single-use devices that are sterilized using Ethylene Oxide (EO). The QuickClear Mechanical Thrombectomy System comprises the following devices and accessories: - QuickClear Aspiration Pump - A 60cc Syringe - QuickClear Aspiration Catheters: Catheters are available in the following sizes: 6F straight tip, 8F straight tip, 8F shaped tip and 10F shaped tip. - An Obturator is supplied with the 8F and 10F catheters. - A Waste Collection Bag

The Phoenix Atherectomy System is intended for use 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. 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 a 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.

The Phoenix Atherectomy System is intended for use in atherectomy of the peripheral vasculature. The system is not intended for use in the coronary, carotid, iliac, pulmonary, or renal vasculature. Phoenix Atherectomy Plus System: When used with the Phoenix Aspiration Pump as the vacuum source, the Phoenix 2.4mm Deflecting Atherectomy System is indicated for the removal of thrombus from vessels of the peripheral arterial vasculature.

The Phoenix 2.4mm Atherectomy Plus System comprises the currently cleared Phoenix 2.4mm Deflecting Atherectomy System (K172386) and a new Phoenix Aspiration Pump. which when used in conjunction with each other are designed for removal of thrombus from vessels of the peripheral arterial vasculature. The Phoenix 2.4mm Deflecting Atherectomy System and the Phoenix Aspiration Pump are sterile, single-use devices that are sterilized using Ethylene Oxide (EO). The Phoenix 2.4mm Deflecting Atherectomy System comprises the Phoenix 2.4mm Deflecting Atherectomy Catheter and the Phoenix Atherectomy Handle with Wire Support Clip. The Phoenix Catheter is an over-the-wire (OTW), multi-lumen Catheter with a cutter at the distal tip that continuously captures and clears debulked (excised) material 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 Atherectorny Catheter at its specified rotational speed, and is activated by an ON/OFF slider switch on the top of the Handle. A Wire Support Clip is used to hold a guidewire in a fixed position relative to the Phoenix 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. The Phoenix Catheter is compatible with commercially available 0.014" exchange length (260 cm or greater) guidewires. For the purpose of this 510(k), the design of the Phoenix 2.4mm Deflecting Atherectomy System remains unchanged. The Phoenix Aspiration Pump connects to the disposal outlet of the Phoenix Catheter via the pump's aspiration tubing. The exit end of the aspiration tubing is connected to a waste disposal bag to collect aspirated material. A 60 ml syringe is provided as part of the Aspiration Pump Assembly to assist in priming the pump aspiration tubing and purging the aspiration system of air. The Aspiration Pump is battery-operated and is operated by an ON/OFF switch. It serves as a vacuum source for the Aspiration System for aspirating the thrombus from the target vessel out of the Phoenix Catheter via the pump aspiration tubing and into the disposal bag. The Aspiration Pump is non-patient contacting.

The Phoenix Atherectomy System is intended for use 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. 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 a 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. These models are available in 1.8 mm and 2.2 mm tip diameter sizes; a 2.4 mm tip diameter size (identical in design to the currently marketed 2.4 mm Phoenix Deflecting Catheter) has been added under this 510(k). 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 149 cm Phoenix Tracking Catheter models to improve the overall catheter pushability and internal debris maceration of the longer length catheter models and (as just noted previously) to also add a 2.4 mm tip diameter 130 cm Phoenix Tracking Catheter to the Phoenix Catheter product family. Tables 9-1 and 9-2 summarize the subject modifications relative to the predicate devices.

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

The AtheroMed 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 three different models of the Phoenix Catheter. Two Phoenix Catheter models track directly over the guidewire with no tip deflection capability. These models are available in 1.8mm and 2.2mm tip diameter sizes. A third, 2.4mm tip diameter model has a Catheter tip design that can be deflected and rotated by the user so that the cutter can eccentrically debulk to a larger diameter than the Catheter's 2.4mm distal cutter. The controls for deflection and rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All three Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260cm or greater) guidewires, and all use the same Phoenix Handle. This 510(k) includes modifications to the cutter and distal assembly of the 1.8mm and 2.2mm tip diameter Phoenix Catheter models, as well as modifications to the Catheter and proximal chassis design, to further optimize the device design and manufacturability of the device. Table 9-1 summarizes the subject modifications relative to the predicate device. Additionally, the Phoenix Guidewire has been added as a compatible guidewire in the product labeling.

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

The AtheroMed 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 Atherectorny 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 three different models of the Phoenix Catheter. Two Phoenix Catheter models track directly over the guidewire with no tip deflection capability. These models are available in 1.8mm and 2.2mm tip diameter sizes. A third, 2.4mm tip diameter model has a Catheter tip design that can be deflected and rotated by the user so that the cutter can eccentrically debulk to a larger diameter than the Catheter's 2.4mm distal cutter. The controls for deflection and rotation are housed in the Phoenix Handle when the Catheter is inserted into the Handle. All three Phoenix Catheter models are compatible with commercially available 0.014" exchange length (260cm or greater) guidewires, and all use the same Phoenix Handle.