Catheters, Transluminal Coronary Angioplasty, Percutaneous

What Is This Device?

A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.

How Is LOX Classified?

Catheters, Transluminal Coronary Angioplasty, Percutaneous is FDA product code LOX, Class 2, 21 CFR 870.5100.

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 19 clearances under this code; the FDA took a median of 147 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 121 recalls under this product code since 2003. None was by a company in China. 20 are Class I, the most serious grade.

The root causes the FDA records most often are Process control (80), Process change control (17) and Process design (3). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.