Product code
NUF: Catheter, neurovasculature, occluding balloon
FDA product code · Class III · Neurology
Key facts
| Product code | NUF |
|---|---|
| Device | Catheter, neurovasculature, occluding balloon |
| Device class | Class III |
| Regulation number | 882.5150 |
| Review panel | Neurology |
| Medical specialty | Neurology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | Yes |
| 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 have failed maximal medical management |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database