FDA product code QTK: Temporary Percutaneous Transluminal Cerebral Artery Dilatation Device
QTK is the FDA product code for temporary percutaneous transluminal cerebral artery dilatation device. It is a HDE device, reviewed by the Neurology panel. Devices under QTK reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
Used to temporarily dilate and increase the diameter of cerebral arteries experiencing symptomatic vasospasm
Classification
| Field | Value |
|---|---|
| Device name | Temporary Percutaneous Transluminal Cerebral Artery Dilatation Device |
| Device class | HDE |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
Recalls for QTK devices
openFDA lists no recalls for product code QTK.
Frequently asked questions
What is FDA product code QTK?
QTK is the FDA product code for temporary percutaneous transluminal cerebral artery dilatation device. It is a HDE device, reviewed by the Neurology panel.
What device class is QTK?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code QTK
- Run a recall and safety report across every QTK manufacturer
- Watch product code QTK 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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