Product code
ORD: Optical coherence tomography, intravascular catheter
FDA product code · Class II · Cardiovascular
Key facts
| Product code | ORD |
|---|---|
| Device | Optical coherence tomography, intravascular catheter |
| Device class | Class II |
| Regulation number | 870.1200 |
| Review panel | Cardiovascular |
| Medical specialty | Cardiovascular |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- None 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