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The ASEPT Glide Peritoneal Drainage System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the ASEPT Glide Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for trans-juqular intrahepatic portosystemic shunt or LVP. The ASEPT Glide Peritoneal Catheter is indicated for adults only.

The ASEPT Glide Peritoneal Drainage System provides patients with a method to drain accumulated fluid from the abdomen. The primary components of the system are the indwelling ASEPT Glide Peritoneal Catheter and the ASEPT Drainage Kit. The catheter is placed in the patient's peritoneal cavity enabling the patient to perform periodic peritoneal drainage at home or in the hospital. The device is provided sterile. The ASEPT Glide Peritoneal Drainage Catheter has a surface modification applied from the distal tip to the polyester cuff.

The PeritX™ Drainage Kits are indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage. The PeritX™ Peritoneal Catheter System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and nonmalignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms relate to recurrent ascites. The use of the PeritX™ Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intra hepatic portosystemic shunt or LVP. The PeritX™ Peritoneal Catheter is indicated for adults only. The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method. For Pleural Use: The PleurX™ LP Catheter Mini Kit is indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for the palliation of dyspnea due to pleural effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX™ Low Profile Catheter is indicated for adults only. For Peritoneal Use: The PleurX™ LP Catheter Mini Kit is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the PleurX™ Low Profile Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The PleurX™ Low Profile Catheter is indicated for adults only. The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method. The PeritX™ Valve Kit is indicated for use in adults only. The PeritX™ Valve Kit is designed for health care facility use only. There is no change to the PeritX™ Valve Kit within this submission. For Pleural Use: The Catheter Access Kit is intended to provide access to the PleurX™ Catheter to inject and withdraw fluids. For Peritoneal Use: The Catheter Access Kit is intended to provide access to the PeritX™ Catheter for aspiration and catheter maintenance. The Lockable Drainage Line is indicated for use only with the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter for intermittent drainage. The Lockable Drainage Line Kit is indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage. The Lockable Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, or other appropriate method (portable suction). The PleurX™ Supplemental Insertion Kit intended to aid in the percutaneous insertion of a PleurX™ Catheter into the pleural space and PeritX™ Catheter into the peritoneal space. The Procedure Pack is indicated for dressing of the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter and exit site. The PleurX™ Drainage Kits are indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage. The PeritX™ Drainage Bag is indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.

The subject device, the PeritX™ Peritoneal Catheter System, includes the PeritX™ Peritoneal Catheter and PleurX™ Low Profile Catheter, sterile, single use indwelling peritoneal catheters, the PeritX™ Valve Kit, Catheter Access Kit, Lockable Drainage Line, Lockable Drainage Line Kit, PleurX™ Supplemental Insertion Kit, Procedure Pack, PleurX™ Drainage Kits, and the PeritX™ Drainage Bag that allow for the management of ascites at home. The PeritX™ Drainage Kit (for vacuum-initiated drainage) is a sterile, single use fluid collection device used with the Peritoneal Catheter to drain fluid from the peritoneal cavity to relieve symptoms associated with malignant and non-malignant ascites. The PeritX™ Drainage Kit includes the PeritX™ Drainage Bag and Procedure Pack. The PeritX™ Drainage Kit is offered in two sizes (1L and 2L).

The Passio Pump Drainage System is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.

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The ASEPT Peritoneal Drainage System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the ASEPT Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The ASEPT Peritoneal Catheter is indicated for adults only.

The ASEPT Peritoneal Drainage System provides patients with a method to drain accumulated fluid from the abdomen. The primary components of the system are the indwelling ASEPT Peritoneal Catheter and the ASEPT Drainage Kit. The catheter is placed in the patient's peritoneal cavity enabling the patient to perform periodic peritoneal drainage at home or in the hospital.

The Aspira Peritoneal Drainage System is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites. •Aspira Drainage Catheter: The Aspira Dramage catheter is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieves symptoms such as dyspnea or other symptoms associated with malignant ascites. • Aspira Drainage Bag: The Aspira Drainage Bag is indicated for use only with the Aspira Valve Assembly for internittent drainage. •Aspira Drainage Bottle: The Aspira Drainage Bottle is indicated for use only with the Aspira Valve Assembly for intermittent drainage. • Aspira Dressing Kit: The Aspira Dressing Kit is indicated for dressing of the drainage catheter and exit site. •Aspira Valve Assembly / Repair Kit: The Aspira Valve Assembly is indicated for use with Aspira, PleurX® and Rocket® catheters. • Aspira Luer Adapter: The Luer Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe, or other appropriate method. · Aspira Universal Tubing Adapter: The Universal Tubing Adapter is intended to provide access to the Aspira Valve Assembly. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe,or other appropriate method.

The Aspira Peritoneal Drainage System provides patients with a convenient method to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites at home. The primary components of the Aspira Peritoneal Drainage System are the Aspira Peritoneal Drainage Catheter, the Aspira Drainage Bag, and the Aspira Drainage Bottle.

The PleurX Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the PleurX Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The PleurX Peritoneal Catheter is indicated for adults only. The PleurX Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.

The PleurX Peritoneal Catheter System provides patients with a convenient method to relieve ascites symptoms. The primary components of the PleurX Peritoneal Catheter System are the PleurX Peritoneal Catheter and the PleurX Drainage Kits.

The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is intermittent drainage of symptomatic. recurrent malignant ascites. Also the palliation of symptoms related to recurrent malignant ascites.

The Rocket Indwelling Peritoneal Catheter (IPC) is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. The catheter has a polyester cuff for attachment to the patient and a silicone one-way valve to prevent air and fluid from migrating back into the peritoneum. The IPC Insertion Kit consists of the IPC, drainage line and accessories for insertion, attachment and dressing. In addition, the Rocket IPC Insertion Kit contains currently licensed 1% lidocaine (5 mL x 3) and DuraPrep (6 mL x 2).

The PleurX Peritoneal Catheter System is indicated for intermittent. Iong term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, and for the palliation of symptoms related to recurrent malignant ascites. The Pleur X Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method. The Pleur X Access Valve attaches only to the PleurX Catheter. The PleurX Valve Kit is intended to repair the PleurX Catheter and replace the Pleur X Valve. The Pleur X LP Catheter Mini Kit is intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, and for the palliation of symptoms related to recurrent malignant ascites.

The PleurX Peritoneal Catheter System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the PleurX Catheter System are the PleurX Peritoneal Catheter and the PleurX Drainage Kits.

The Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit is intermittent drainage of symptomatic, recurrent malignant ascites. Also the palliation of symptoms related to recurrent malignant ascites.

Rocket Medical Plc. hereby submits this Traditional 510(k) notice for its Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit. The Rocket Indwelling Peritoneal Catheter is a fenestrated silicone drainage catheter intended for the drainage of peritoneal ascites. There is a polyester cuff for attachment to the patient and a silicone one-way valve to prevent air and fluid from migrating back into the peritoneum. The IPC Insertion Kit will consist of the IPC and components necessary for its use such as a drainage line. In addition, the Rocket IPC is packaged into convenience kits to aid in the implantation of the Rocket IPC.

The Pleux Peritoneal Catheter System is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant ascites that does not respond to medical management of the underlying disease, for the palliation of symptoms related to recurrent malignant ascites and for peritoneal placement only. The Pleurx Drainage Bottle Kits and Drainage Line Set are indicated for use either with the Pleurx Peritoneal Catheter or Pleural Catheter for intermittent drainage. The Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle or other appropriate method. The Pleurx Drainage Bag Kit is indicated for use only with the Pleurx Peritoneal Catheter for intermittent drainage. The Pleurx Dressing Kits are indicated for dressing of a catheter and exit site. The Pleurx Catheter Access Kit is intended to provide access to the Pleurx Catheter for aspiration and catheter maintenance. The Pleurx Catheter Insertion Stylet is intended to aid in the percutaneous insertion of the Pleurx Catheter into the peritoneal space. The Valved Peelable Introducers are intended for use in the percutaneous insertion of a catheter into the peritoneal space.

The Pleurx Peritoneal Catheter System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the Pleurx Catheter System are the Pleurx Periloneal Catheter and the Pleurx Drainage Kits.