Product code
QTK: Temporary percutaneous transluminal cerebral artery dilatation device
FDA product code · HDE · Neurology
Key facts
| Product code | QTK |
|---|---|
| Device | Temporary percutaneous transluminal cerebral artery dilatation device |
| Device class | HDE |
| Review panel | Neurology |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Used to temporarily dilate and increase the diameter of cerebral arteries experiencing symptomatic vasospasm |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- 1–9 HDE approvals
- 1–9 UDI devices (GUDID)
- None 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