Catheter, Angioplasty, Peripheral, Transluminal

How Is LIT Classified?

Catheter, Angioplasty, Peripheral, Transluminal is FDA product code LIT, Class 2, 21 CFR 870.1250.

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 10 clearances under this code; the FDA took a median of 199 days from receipt to decision on them.

One went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Do the Recalls Say?

The FDA has recorded 32 recalls under this product code since 2003. 1 was by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are Process change control (4), Process control (4) and Device Design (3). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.