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 Bearpac Medical.
FDA 510(k) Cleared Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling Devices (Product Code PNG)
About Product Code PNG - Regulatory Context
510(k) Submission Activity
15 total 510(k) submissions under product code PNG since 2005, with 15 receiving FDA clearance (average review time: 161 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under PNG have taken an average of 205 days to reach a decision - up from 154 days historically. Manufacturers should account for longer review timelines in current project planning.
PNG devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →