Definition: Call For PMAs - 12/26/96 Per 61 FR 50708 On 9/27/96 - For The Treatment Of Cerebral Ischemia Resulting From Symptomatic Vasospasm Following Aneurismal Subarachnoid Hemorrhage, Secured By Either Surgical Or Endovascular Intervention For Patients Who H
| Device Type ID | 3754 |
| Device Name | Catheter, Neurovasculature, Occluding Balloon |
| Regulation Description | Intravascular Occluding Catheter. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | PMA |
| CFR Regulation Number | 882.5150 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NUF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3754 |
| Device | Catheter, Neurovasculature, Occluding Balloon |
| Product Code | NUF |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Intravascular Occluding Catheter. |
| CFR Regulation Number | 882.5150 [🔎] |
| Device Problems | |
|---|---|
Burst Container Or Vessel | 2 |
Deflation Problem | 1 |
Break | 1 |
| Total Device Problems | 4 |