FDA product code OBA: Polymerizing, Neurovascular Embolization Material
OBA is the FDA product code for polymerizing, neurovascular embolization material. It is a HDE device, reviewed by the Neurology panel. Devices under OBA reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
The neurovascular embolization device is placed in a blood vessel to permanenty obstruct blood flow to an intracranial aneurysm or other vascular malformation. The device polymerizes or precipitates in situ.
Classification
| Field | Value |
|---|---|
| Device name | Polymerizing, Neurovascular Embolization Material |
| Device class | HDE |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Recalls for OBA devices
openFDA lists no recalls for product code OBA.
Frequently asked questions
What is FDA product code OBA?
OBA is the FDA product code for polymerizing, neurovascular embolization material. It is a HDE device, reviewed by the Neurology panel.
What device class is OBA?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code OBA
- Run a recall and safety report across every OBA manufacturer
- Watch product code OBA 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.
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