Catheter, Hemodialysis, Non-Implanted

What Is FDA Product Code MPB?

Catheter, Hemodialysis, Non-Implanted is FDA product code MPB, Class 2, 21 CFR 876.5540.

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. Chinese applicants hold 1 clearance under this code; the FDA took 415 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 24 recalls under this product code since 2003. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Process control (14), Material/Component Contamination (2) and Labeling Change Control (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.