Product code
NPE: Material, embolization, neurovascular, polymerizing or precipitating
FDA product code · Class III · Neurology
Key facts
| Product code | NPE |
|---|---|
| Device | Material, embolization, neurovascular, polymerizing or precipitating |
| Device class | Class III |
| Review panel | Neurology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | Yes |
| Definition | This is an neurovascular embolization device which is placed in a blood vessel to permanently obstruct blood flow to an aneurysm or other vascular malformation. It is unlike the coil or particulate embolization devices in that it polymerizes or precipitates in situ. Particulate or coil-based embolic agents are delivered in pre-formed shapes and configurations. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- 1–9 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