← FDA Medical Device Classifications
Optical Coherence Tomography, Intravascular Catheter
ORD · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1200
Classification
- FDA Product Code
ORD- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 870.1200
- Review panel
- CV
- Medical specialty
- Cardiovascular
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 9
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown