Product code
QCA: Intracranial coil-assist stent
FDA product code · Class III · Neurology
Key facts
| Product code | QCA |
|---|---|
| Device | Intracranial coil-assist stent |
| Device class | Class III |
| Review panel | Neurology |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | An intracranial coil-assist stent is a tubular device placed in an artery in the brain to assist in the placement and retention of embolic coils for the treatment of wide-neck intracranial aneurysms. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 100–999 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