Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

How Is FOZ Classified?

Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days is FDA product code FOZ, Class 2, 21 CFR 880.5200.

How Does It Reach the US Market?

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 5 clearances under this code; the FDA took a median of 261 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 394 recalls under this product code since 2002. None was by a company in China. 7 are Class I, the most serious grade.

The root causes the FDA records most often are Nonconforming Material/Component (122), Process control (59) and Process design (18). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.