Device |
percutaneous catheter, ultrasound |
Regulation Description |
Percutaneous catheter. |
Definition |
Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature. |
Physical State |
Catheters that deliver electro-mechanical energy to a blood vessel via a catheter which is connected via a cable to a generator. |
Technical Method |
Delivered through the peripheral arterial system. Use of shockwave to disrupt plaque or blood clot. |
Target Area |
Peripheral Vasculature |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | PPN |
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
|
Third Party Review |
Not Third Party Eligible |