Product code ORD
- Device name
- Optical Coherence Tomography, Intravascular Catheter
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1200
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures.
- Source
- FDA openFDA device classification dataset