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The Glidewire is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

The Radifocus Glidewire is a guide wire which is designed to fit inside a percutaneous catheter for the purpose of directing a catheter through the blood vessel. It is provided sterile and is intended for single use only. It consists of a Nickel Titanium alloy core wire; a polyurethane coating (containing tungsten) and a hydrophilic polymer coating are applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled, and two types of flexible part lengths of the tip: 3 and 5cm. The Radifocus Glidewire is packaged in a plastic holder that is contained within an individual package. A guide wire inserter is included within the individual package to assist with the insertion of the guide wire into a catheter.

The Radifocus Optitorque Angiographic Catheter is indicated for use in cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery.

The Radifocus Optitorque Angiographic Catheter is comprised of a two-layer construction featuring stainless steel mesh sandwiched between layers of polyurethane and polyamide elastomers. The shaft inner layer and outer layer contain barium sulfate for visibility and contrast under fluoroscopy. A soft tip is attached to the distal portion of some 4 Fr and all 5 Fr and 6 Fr catheters except those with a pigtail design; a soft tube is attached to the distal portion of 5 Fr and 6 Fr catheters with a pigtail design; the 4 Fr products are available with or without a soft tip. Constructed of flexible, supple polyurethane that is permanently welded to the catheter shaft, the soft tip and soft tube are designed to minimize trauma to the vessel wall. There is no change to the design of the device as a result of this submission. The device is offered in lengths of 65-120 cm. French sizes and shaft inner diameters are as follows: French Size | Shaft Inner Diameter ---|--- 4 | 1.05mm 5 | 1.22mm 6 | 1.32mm It is a disposable device intended for single use only. This device is individually packaged and sterilized by ethylene oxide gas.

The Capiox FX Hollow Fiber Oxygenator and Arterial Filter is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery. The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit. The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device. The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The 3-liter and 4-liter reservoirs may be used for Vacuum Assisted Drainage procedures and Post Operative Chest Drainage Procedures. The Capiox FX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min. when used with a 3 Liter Reservoir. The Capiox FX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min. The Capiox FX Oxygenator/Reservoir/Arterial Filter assemblies can be used in procedures lasting up to 6 hours.

The modified Capiox® FX15 and FX25 Oxygenator utilizes porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion. The modified Capiox® FX15 and FX25 device has an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as a heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood. With respect to the filtration of arterial blood, the modified Capiox® FX15 and FX25 Oxygenator/Reservoir relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood. The subject of this Special 510(k) is a modification being made to the detachable Hardshell Reservoir. The design of the Hardshell Reservoir component remains identical to the design of the original reservoir that was cleared by FDA with K071494 -- except that a positive pressure relief valve will be included on the lid of the reservoir. The materials that are used in the construction of the Capiox® FX15 and FX25 Oxygenator/Reservoir, but are not limited to, nylon, polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™. The positive pressure relief valve that is included with the modified reservoir is constructed of polycarbonate and nylon.