| Device |
optical coherence tomography, intravascular catheter |
| Regulation Description |
Diagnostic intravascular catheter. |
| Definition |
For intravascular visualization of the coronary vessel lumen and wall in patients who are candidates for transluminal interventional procedures. |
| Physical State |
A flexible intravascular catheter provides optical delivery and sensing of laser light to produce images of the vessel lumen and wall on its associated imaging system using optical coherence tomography technology. |
| Technical Method |
A flexible intravascular catheter provides optical delivery and sensing of laser light to produce images of the vessel lumen and wall on its associated imaging system using optical coherence tomography technology. |
| Target Area |
Coronary vasculature |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | ORD |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.1200
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
