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The NavajoTM PTA balloon dilatation catheter is intended to dilate stenoses in the peripheral arteries (iliofemoral, popliteal, infra popliteal, renal arteries); and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Navajo™ PTA Balloon Dilatation Catheter is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal adaptor, coaxial lumen shaft, and a distal dilatation balloon. The Navajo PTA Balloon Dilatation Catheter is compatible with guide wires with a maximum diameter of 0.035" and with 5F to 7F introducer sheaths, depending on the diameter and balloon length of the dilatation balloon. The catheter is provided with a hydrophilic coating on the shaft and is available in useable catheter lengths of 80, 100, 120 and 130cm.

The Curasa AUTO CPAP (Continuous Positive Airway Pressure) with heated humidifier system is intended for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is for use in the home or hospital /institutional environment.

The Curasa AUTO CPAP System with heated humidifier is used on adult patients for treatment of obstructive sleep apnea (OSA). The Auto CPAP system provides a stable continuous positive airway pressure (CPAP). The Auto mode detects breathing phenomena (e.g. snore, hypopnea) and automatically adjusts the delivered pressure. The humidifier provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. The Curasa AUTO CPAP system includes the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier. All of the accessories provided with the Curasa AUTO CPAP are identical to those provided with the predicate Curasa CPAP SD (K123897). The Auto CPAP system has been modified based Curasa CPAP SD (K123897) hardware and software. The design of the humidifier and humidifier interface is identical to the referenced predicate device (Curasa CPAP SD, K123897). The basic function and performance characteristics of Curasa AUTO CPAP are similar to the referenced predicate device (Curasa CPAP SD K123897). The Auto mode of operation is similar to the referenced predicate, Respironics Remstar Auto CPAP (K012554).

The K Series CPAP System, is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is intended to be used in the home or hospital/institutional environment.

The K Series CPAP systems are used on adult patients for treatment of obstructive sleep apnea (OSA). The K Series CPAP Systems has 3 commercially available models, Curasa CPAP (K120285), Floton CPAP (K120285), and Curasa CPAP SD (K123897). This 510(k) application adds the Curasa CPAP EUT model to the currently commercially available selection of models. as well as the AutoManager PC Software accessory. The K series CPAP system provides a stable continuous positive airway pressure (CPAP). The humidifier, which works with all the K Series CPAP Systems, provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. Each K Series CPAP system also includes the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier. The Curasa CPAP EUT has the same electronic design and similar software as the Curasa CPAP SD, except for the addition of EUT (expiratory unload trigger) feature. The EUT feature detects patient exhalation phase and reduces output pressure. EUT feature has 3 levels of pressure reduction. The CPAP EUT also works with a special accessory PC software tool, AutoManager™ AutoManager™ is used by the service provider to analyze the patient's CPAP compliant data and, if needed, update the CPAP pressure setting via the CPAP's SD card. The AutoManager™ software collects/updates CPAP device data via an SD card. The AutoManager™ PC software is an independent accessory to the CPAP device and runs on a stand-alone PC and not on the CPAP device itself.

The BestFit™ and BestFit™2 Nasal Masks are intended for multiple use on adult patients (body weight >30kg) prescribed with using continuous positive airway pressure (CPAP) or bilevel ventilator system in hospital, clinic and/or home environment.

The BestFit™ Nasal Masks are patient interface devices used on adult patients prescribed with CPAP and Bi-Level Positive Airway Pressure therapy. The BestFit product family consists of two models, BestFit and and BestFit 2. Both models have same function and performance, except for a slight difference in the forehead design. Both devices are vented and can be used multiple times in a hospital, clinical and/or home environment. The nasal mask style covers and seals around the patient's nose and delivers positive pressure from the therapy device to the patient via the patient air circuit of the CPAP device. The BestFit Nasal Masks include the following accessories: headgear and Instructions for Use (IFU). The model BestFit Nasal mask is available in 4 different sizes: Small (S), Medium (M), Large (L), and Medium Wide (MW). The model BestFlt 2 Nasal mask is available in 3 different sizes: Small (S), Medium (M), and Large (L).

The K Series CPAP System, is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is intended to be used in the home or hospital/institutional environment.

The K Series CPAP systems are used on adult patients for treatment of obstructive sleep apnea (OSA). The K Series CPAP Systems has 2 commercially available models, Curasa CPAP and Floton CPAP (K120285). This special 510(k) adds the Curasa CPAP SD model to the currently commercially available selection of models. The K series CPAP system provides a stable continuous positive airway pressure (CPAP). The humidifier, which works with all the K Series CPAP Systems, provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. Each K Series CPAP system also includes the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier. The Curasa CPAP SD has similar electronic design and software as the Curasa CPAP, except for the addition of a SD card interface and associated software driver. The Curasa CPAP SD can store/read CPAP patient compliance data onto a SD card where it can be viewed by an external PC.

The K Series CPAP with Heated Humidifier System is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is intended to be used in the home or hospital/institutional environment.

The K Series CPAP Systems with heated humidifier are used on adult patients for treatment of obstructive sleep apnea (OSA). The K Series CPAP Systems are available in two models: Curasa model and Floton model. The CPAP system provides a stable continuous positive airway pressure (CPAP). The humidifier works only with the K Series CPAP Systems and provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. The K Series systems also include the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier.