FDA product code QCA: Intracranial Coil-Assist Stent
QCA is the FDA product code for intracranial coil-assist stent. It is a Class III device, reviewed by the Neurology panel. Devices under QCA reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 2 recalls for QCA devices, 2 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Intracranial Coil-Assist Stent |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QCA devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-04-06.
| Year | Recalls |
|---|---|
| 2024 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code QCA?
QCA is the FDA product code for intracranial coil-assist stent. It is a Class III device, reviewed by the Neurology panel.
What device class is QCA?
Class III. Typical premarket route: PMA.
Have QCA devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2026-04-06.
Next steps
- Run an FDA pathway report with predicate devices for product code QCA
- Run a recall and safety report across every QCA manufacturer
- Watch product code QCA 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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