Peritoneal, Drainage Catheter for Refractory Ascites, Long-Term Indwelling

What Is This Device?

For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.

How Is PNG Classified?

Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling is FDA product code PNG, Class 2, 21 CFR 876.5630.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 13 recalls under this product code since 2023. None was by a company in China. The root cause the FDA records most often is Process control (13).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.