Product code
LOX: Catheters, transluminal coronary angioplasty, percutaneous
FDA product code · Class II · Cardiovascular
Key facts
| Product code | LOX |
|---|---|
| Device | Catheters, transluminal coronary angioplasty, percutaneous |
| Device class | Class II |
| Regulation number | 870.5100 |
| Review panel | Cardiovascular |
| Medical specialty | Cardiovascular |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- 10–99 PMA approvals
- None HDE approvals
- 1,000+ UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- 100–999 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database