PleurX Peritoneal Catheter System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K160437 ↗

FDA Product Code

PNG

Device Class

Class II

Regulation

21 CFR Part 876.5630

Advisory Committee

Gastroenterology, Urology

FDA Decision

SEKD

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  FDA 510(k) K121849 Active Cleared 18 Oct 2012

• PleurX Peritoneal Catheter System

  Class II

  FDA 510(k) K201155 Active Cleared 21 Oct 2020

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See all devices from Carefusion →

• What is the PleurX Peritoneal Catheter System used for?

  The PleurX Peritoneal Catheter System is designed for intermittent, long-term drainage of symptomatic, recurrent malignant ascites that does not respond to medical management of the underlying disease. It is used for palliation of symptoms related to recurrent malignant ascites and is intended for peritoneal placement only.

• What components are included in the PleurX Peritoneal Catheter System?

  The system is supplied as a catheter kit and includes placement trays, starter kits, drainage kits, and accessories. These components are designed to facilitate the proper placement and use of the catheter for draining ascites from the peritoneal cavity.

• Is the PleurX Peritoneal Catheter System reusable or single-use?

  The PleurX Peritoneal Catheter System is designed for long-term indwelling use, meaning it remains in place over time for repeated drainage procedures. However, the specific drainage kits and accessories may be single-use items, depending on the component. Always follow the instructions for use provided with the device.

• What is the regulatory classification of the PleurX Peritoneal Catheter System?

  The PleurX Peritoneal Catheter System is a Class II medical device regulated under product code PNG with FDA 510(k) clearance. It is manufactured by Care Fusion and is not indicated for MRI use. Storage and handling instructions should be followed as provided in the device's instructions for use manual.