FDA product code OVC: Headframe
OVC is the FDA product code for headframe. It is a Not classified device, reviewed by the Neurology panel. Devices under OVC reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
Definition
To enhance mechanical thrombus dissolution and acceleration of thrombolysis in patients suffering acute ischemic stroke.
Classification
| Field | Value |
|---|---|
| Device name | Headframe |
| Device class | Not classified |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| GMP exempt | Yes |
Recalls for OVC devices
openFDA lists no recalls for product code OVC.
Frequently asked questions
What is FDA product code OVC?
OVC is the FDA product code for headframe. It is a Not classified device, reviewed by the Neurology panel.
What device class is OVC?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code OVC
- Run a recall and safety report across every OVC manufacturer
- Watch product code OVC 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.