| Device |
balloon aortic valvuloplasty |
| Regulation Description |
Balloon aortic valvuloplasty catheter. |
| Definition |
A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve. |
| Physical State |
Generally, a balloon aortic valvuloplasty catheter is a coaxial catheter comprised of outer and inner layers. The catheter features a molded proximal end bifurcated with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon made of polyamide. Upon reaching a specified pressure, the waist will expand to the rated balloon diameter and dilate the valve to the rated diameter. |
| Technical Method |
The catheter is inserted into the body and directed towards the aortic valve. Once the catheter is placed in the valve, the balloon is expanded which compresses and/or breaks the material causing stenosis. |
| Target Area |
The aortic valve of the heart. |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | OZT |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.1255
|
|---|
| 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 |
