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 |