Syringe, Balloon Inflation

How Is MAV Classified?

Syringe, Balloon Inflation is FDA product code MAV, Class 2, 21 CFR 870.1650.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 2 clearances under this code; the FDA took a median of 307 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 29 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Component change control (9), Packaging process control (3) and Device Design (2).

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