| Device |
percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures |
| Definition |
The device is a single use percutaneous catheter system intended for mechanically splitting aortic valve leaflets that may prevent coronary artery ostia obstruction during planned transcatheter valve procedures. |
| Physical State |
The device is a non-implantable, single-use, percutaneous catheter system with mechanical cutting element(s) at the distal end |
| Technical Method |
The device is a single-use percutaneous catheter system that will reach the target area through the vasculature and will cut the aortic leaflet(s) using mechanical forces, such as slicing or cutting actions. |
| Target Area |
Aortic valve leaflets, native or bioprosthetic |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | SCZ |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.1254
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
