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Drainage of persistent ascites from the abdominal cavity into the venous system, for use in patients with: *chronic liver disease whose ascites has not responded to surgical correction of their portal hypertension nor to standard medical management *persistent ascites who are not considered candidates for portal-venous shunting *persistent ascites which is non-responsive to standard medical management *primary or metastatic intra-abdominal neoplasms with massive ascites to help relieve intra-abdominal pressure *persistent ascites with hepatorenal syndrome, chylous ascites, and idiopathic ascites

The devices have the same intended use, materials, configuration and dimensional specifications as the currently marketed Denver® Ascites Shunts (K894756) and Denver® Ascites Shunt Percutaneous Access Kits (K913728). The devices differ in that: The devices covered by this submission undergo a surface 1) treatment as part of the manufacturing process. No TDMAC-Heparin is applied to the devices covered by this 2) submission.

The Denver® PLEURX Pleural Catheter Kit and Denver® PLEURX Home Drainage Kit are indicated for intermittent, longterm drainage of symptomatic, recurrent, malignant pleural effusion. The devices are indicated for the palliation of dyspnea due to malignant pleural effusion and for providing pleurodesis.

The Denver® PLEURX Pleural Catheter Kit (#50-7000) is a sterile device, for single use only, and is not to be resterilized. The kit contains the PLTURX Catheter; a specifically matched drainage line that can be configured for either wall suction or a vacuum bottle; and the components needed to place the catheter within the pleural space and to dress the catheter exit site after placement. The PLEURX Catheter contained in the kit is a flexible, fenestrated silicone catheter with a cuff and a valve. The fenestrated portion of the catheter is inserted into the pleural space utilizing a peel-away introducer (Seldinger technique). The portion of the catheter containing the cuff is tunneled subcutaneously, and the remaining portion is left external to the body. A radiopaque stripe runs the entire length of the catheter. The Denver® PLEURX Home Drainage Kit (#50-7500), an accessory to the Denver® PLEURX Pleural Catheter Kit, is a sterile, disposable device designed for single use only, and is not to be resterilized. The kit contains drainage lines, vacuum bottles, and the components needed to drain the effusion and to redress the catheter exit site.

The Denver® Pleural Effusion Shunt with External Pump Chamber, Catalog No. 42-9005 is indicated for use in transferring pleural fluid, resulting from chylothorax or intractable pleural effusion, from the pleural cavity to the peritoneal cavity.

The Denver® Pleural Effusion Shunt with External Pump Chamber is a sterile, non-pyrogenic device, for single use only. It is not to be resterilized. The one-piece device consists of a 15.5 Fr. fenestrated pleural catheter and a 15.5 Fr. fenestrated peritoneal catheter, separated by a flexible pump chamber containing two one-way valves. The flexible pump chamber is designed to be manually pumped by the patient or caregiver to transfer pleural fluid from the pleural cavity into the peritoneal cavity. The valves in the pump chamber permit flow in one direction only. The second valve in the pump chamber serves as a check valve for the first, helping to prevent reflux of fluid into the peritoneal catheter when the pump chamber is pumped . Each catheter has a polyester cuff located between the pump chamber and the catheter's fenestrations. When the device is placed in a patient, the pleural and peritoneal catheters are implanted into the pleural and peritoneal cavities, respectively, with the cuffs subcutaneous to permit tissue ingrowth into the cuff. The pump chamber remains outside the patient's body. The entire device is made of silicone rubber, with the exception of the cuffs, which are polyester. Both the pleural and peritoneal catheters contain an integral barium sulfate stripe to permit visualization by x-ray or fluoroscopy.

The Denver® Paracentesis Needle, Paracentesis Needle with Drainage Binc, and the Denver Traracentesis Tray are indicated for use in removing from cac personed to be used for both diagnostic and therapeutic abdominal paracentesis procedures.

The Denver® Paracentesis Needle is a sterile device, for single use only. It is not to be resterilized. Components in the fluid path are non pyrogenic. This device consists of an inner two-part trocar, an outer drainage cannula, and a trocar/cannula housing. The inner two-part trocar is a rounded, closed end tube with side holes, coaxially housed within a sharp-beveled hollow needle and the outer drainage cannula. The outer drainage cannula has a beveled tip and distal side holes to facilitate drainage. As the two-part trocar penetrates the abdominal wall, the blunt portion of the trocar is forced back within the shaft of the needle portion of the trocar, exposing the sharp-beveled needle. The trocar/cannula housing contains a red indicator which is visible when the sharp-beveled needle is exposed. When the needle encounters low resistance, such as when the abdominal cavity is entered, the blunt portion of the trocar automatically re-extends out beyond the sharp needle, thereby helping protect against inadvertent organ puncture. Once the blunt portion of the trocar re-extends beyond the needle, the red indicator is no longer visible. Proper position in an area of fluid may also be confirmed by attaching a syringe to the end of the device and attempting aspiration. Once in the abdominal cavity, the two-part trocar is removed, leaving the outer drainage cannula and housing in place for the paracentesis procedure. The Denver® Paracentesis Needle with Drainage Line is a sterile device intended for single use only. It is not to be resterilized. The product contains one Denver® Paracentesis Needle, one drainage tubing line, and connectors to allow attachment to wall suction or a vacuum bottle. The Denver® Paracentesis Tray is a sterile device intended for single use only. It is not to be resterilized. The tray contains one Denver® Paracentesis Needle, one drainage tubing line, connectors to allow attachment to wall suction or a vacuum bottle, and the primary components needed for performing the paracentesis procedure.