Product code
OBA: Polymerizing, neurovascular embolization material
FDA product code · HDE · Neurology
Key facts
| Product code | OBA |
|---|---|
| Device | Polymerizing, neurovascular embolization material |
| Device class | HDE |
| Review panel | Neurology |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | Yes |
| 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. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- 1–9 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