ORD — Optical Coherence Tomography, Intravascular Catheter Class II
FDA product code ORD covers "Optical Coherence Tomography, Intravascular Catheter", a Class II medical device regulated under 21 CFR 870.1200. Submissions are reviewed by the Cardiovascular panel.
Classification Details
- Product Code
- ORD
- Device Class
- Class II
- Regulation Number
- 870.1200
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures.