| Device |
catheter, intravascular, plaque morphology evaluation |
| Regulation Description |
Diagnostic intravascular catheter. |
| Definition |
Catheter used for delivery of a sensing modality to a coronary or peripheral artery region for determination of atherosclerotic plaque characteristics. For examination of morphologic features of coronary or peripheral artery lesions or plaques. |
| Physical State |
Flexible intravascular catheter with plaque diagnostic modality at the tip. |
| Technical Method |
The device is inserted into the arterial segment of interest, and using its sensing technology, obtains information on the characteristics of the arterial wall. The characteristics are captured digitally and filtered with a software algorithm, and the arterial wall and lesion characteristics are presented to the user via a user interface. |
| Target Area |
Coronary or peripheral arteries. |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | OGZ |
|---|
| 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 |
