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The DirectVision® Catheter, Uncoated is indicated for use in the drainage and/or collection and/or measurement of urine. It is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as the nephrostomy tract.

The DirectVision® Catheter,-Uncoated is a flexible tubular device that is inserted through the urethra and used to pass fluids to and from the urinary tract. It is a 100% silicone, latex-free, triple lumen (3-Way) Foley catheter with a straight or angled council tip to facilitate insertion. The DirectVision® Catheter, Uncoated is composed of a silicone tube that trifurcates into three (3) lumens, a silicone balloon, and a two-way valve. Of the three lumens, one lumen is used for urinary drainage and can be connected to a urine collection container (drainage bag or urine meter); one lumen has a two-way valve for inflation/deflation of the Foley balloon; and the third lumen can be used for irrigation of the bladder. The council tip has an opening (eyelet) in the tip that can be used to pass a guidewire or similar device to facilitate catheter insertion. This catheter device will be available with a single or double drainage eyelet, 14 through 24 French shafts, and either a 10 cc or 30 cc balloon. The DirectVision® Catheter, Uncoated is designed to be usable with the PercuVision DirectVision™ Guide System (K091600). In the DirectVision™ Guide System, the DirectVision® Catheter, Uncoated provides a sheath around the microendoscope to facilitate its use. The catheter also incorporates a channel to be used for supplying irrigation to the microendoscope tip for clearing away debris from the field of view during use.

The DirectVision" Guide System is indicated for use in the visual examination of the urethra and bladder when placing the PercuCath Urologic Catheter.

The DirectVision™ Guide System is comprised of two (2) distinct components: a flexible semirigid microendoscope, and a handheld camera with integral LED illumination and camera control unit (CCU). The microendoscope is designed to work with the Schoelly Imaging Inc. FSC2 light source and CCU (K090601). The DirectVision TM Guide System is indicated for use in the endoscopic examination of the urethra and bladder, when placing the PercuCath™ Urologic Catheter (K090262). The catheter provides a sheath around the microendoscope to facilitate its use. The catheter also incorporates a channel to be used for supplying irrigation to the microendoscope tip for clearing away debris from the field of view during use. The microendoscope coupler is connected to the cleared camera and integral light source such that the light source is collinear with the light fiber optic bundle and the camera is collinear with the image fiber optic bundle. The image transmitted through the image fiber optic bundle to the camera is then displayed on a monitor accessory for the clinician to view.

The PercuCath™ Catheter is indicated for use in the drainage and/or collection and/or measurement of urine. It is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as the nephrostomy tract.

The PercuCath™ Urinary Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to and from the urinary tract. The PercuCath™ Urinary Catheter is a 100% silicone, latex-free, triple lumen (3-Way) Foley catheter with a lubricious hydrophilic coating and a straight or angled council tip to facilitate insertion. It is composed of a silicone tube that trifurcates into three lumens, a silicone balloon, and a two-way valve. When activated, the valve permits flow in either of two directions, i.e., for inflation or deflation of the balloon. Of the three lumens, one lumen is used for urinary drainage and can be connected to a urine collection container (drainage bag or urine meter); one lumen has a two-way valve for inflation/deflation of the Foley balloon; and, the third lumen can be used for irrigation of the bladder. The council tip has an opening (eyelet) in the tip that can be used to pass a guidewire or similar device to facilitate catheter insertion. The PercuCath™ Urinary Catheter will be available with a single eyelet or double eyelet, 14 through 24 Fr. Shafts (i.e.,14, 16, 18, 20, 22, and 24), and either a 10 cc or 30 cc balloon.