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.
| Device Type ID | 3632 |
| Device Name | Ultrasound, Infusion, System |
| Regulation Description | Diagnostic Intravascular Catheter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NUI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3632 |
| Device | Ultrasound, Infusion, System |
| Product Code | NUI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Intravascular Catheter. |
| CFR Regulation Number | 870.1200 [🔎] |
| Device Problems | |
|---|---|
High Test Results | 1 |
| Total Device Problems | 1 |