| Device |
catheter, percutaneous, cutting/scoring |
| Regulation Description |
Percutaneous catheter. |
| Definition |
To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material |
| Physical State |
Cutting/scoring catheters are usually comprised of flexible polymers for the catheter body and a compliant polymer for the balloon. The cutting/scoring elements are usually metal. |
| Technical Method |
The device is typically placed using a guidewire and guiding catheter. The active end is typically expanded and the cutting/scoring surfaces are apposed to the vessel wall to cause cracking or breaking of the stenosis. |
| Target Area |
Peripheral arteries and arteriovenous dialysis fistulae |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | PNO |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Coronary and Peripheral Interventional Devices
(DHT2C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.1250
|
|---|
| 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
|
|---|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
