FDA Product Code PNG: Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
Refractory ascites from liver cirrhosis or malignancy can be managed with long-term drainage systems. FDA product code PNG covers peritoneal drainage catheters for chronic ascites management.
These tunneled catheters are placed under ultrasound guidance to provide repeated ambulatory drainage of peritoneal fluid, allowing patients to drain ascites at home without repeated paracentesis visits. They improve quality of life in patients with malignant and refractory cirrhotic ascites.
PNG devices are Class II medical devices, regulated under 21 CFR 876.5630 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include Pfm Medical, Inc., Merit Medical Systems, Inc. and Bard Peripheral Vascular, Inc..
List of Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling devices (product code PNG). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →