| Device |
ultrasound, infusion, system |
| Regulation Description |
Diagnostic intravascular catheter. |
| Definition |
For regional infusion of contrast materials into selected vessels in the neuro-vasculature.The device may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature. |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Neurology |
|---|
| Product Code | NUI |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.1200
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
