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The OutFlo Aortic Valve Dilatation Balloon Catheter is indicated for balloon aortic valvuloplasty.

The OutFlo Aortic Valve Dilatation Balloon Catheter (marketing name: OutFlo) is a sterile, single use, Over-the-Wire (OTW) dual-lumen catheter with a hub at the proximal end and a balloon cluster at the distal end. The proposed device consists of a series of parallel balloons on a catheter which, when deployed, provides an outward radial force while also creating an inter balloon space or passage for blood flow. Thus, buildup of pressure in the ventricle is avoided. The dilation catheter is intended to be used in conjunction with a 14F or larger guiding catheter and a 0.035" or smaller guidewire, and Y-connectors, none of which are supplied by the manufacturer. The OutFlo Aortic Valve Dilatation Balloon Catheter is provided in five models. The only difference between the models are the balloon diameter.

The Trachealator is indicated for use in dilatation techniques to open or expand stenosis in the airway.

The D35 Airway Dilation Catheter (marketing name: Trachealator) is a sterile single-use device used during airway dilatation procedures. The proposed device consists of a series of parallel balloons on a catheter which, when deployed, provides an outward radial force while also creating an inter balloon space or passage for airflow. Thus, airway occlusion is avoided. The D35 Airway Dilation Catheter is also packaged with a double-ended PTFE-coated stainlesssteel guidewire. The guidewire consists of a two-tip configuration with a length of 1500 mm. One end has a straight tip configuration, while the other end consists of a J-tip with a 6 mm diameter. The catheter is also used with an inflation device that is not provided with the catheter. The D35 Airway Dilation Catheter is provided in nine models. The only differences between the models are the balloon length and diameter.