FDA product code NUF: Catheter, Neurovasculature, Occluding Balloon
NUF is the FDA product code for catheter, neurovasculature, occluding balloon. It is a Class III device, regulated under 21 CFR 882.5150 and reviewed by the Neurology panel. Devices under NUF reach the market by PMA; FDA lists no cleared 510(k)s for it.
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
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Neurovasculature, Occluding Balloon |
| Device class | Class III |
| Regulation | 21 CFR 882.5150 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for NUF devices
openFDA lists no recalls for product code NUF.
Frequently asked questions
What is FDA product code NUF?
NUF is the FDA product code for catheter, neurovasculature, occluding balloon. It is a Class III device, regulated under 21 CFR 882.5150 and reviewed by the Neurology panel.
What device class is NUF?
Class III, regulation 21 CFR 882.5150. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NUF
- Run a recall and safety report across every NUF manufacturer
- Watch product code NUF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times