FDA product code ORD: Optical Coherence Tomography, Intravascular Catheter
ORD is the FDA product code for optical coherence tomography, intravascular catheter. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel. Devices under ORD reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures.
Classification
| Field | Value |
|---|---|
| Device name | Optical Coherence Tomography, Intravascular Catheter |
| Device class | Class II |
| Regulation | 21 CFR 870.1200 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for ORD devices
openFDA lists no recalls for product code ORD.
Frequently asked questions
What is FDA product code ORD?
ORD is the FDA product code for optical coherence tomography, intravascular catheter. It is a Class II device, regulated under 21 CFR 870.1200 and reviewed by the Cardiovascular panel.
What device class is ORD?
Class II, regulation 21 CFR 870.1200. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code ORD
- Run a recall and safety report across every ORD manufacturer
- Watch product code ORD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.