FDA product code QKJ: Stent, Central Venous
QKJ is the FDA product code for stent, central venous. It is a Class III device, reviewed by the Cardiovascular panel. Devices under QKJ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
A central venous stent is a prescription device for maintaining the luminal diameter of the central veins.
Classification
| Field | Value |
|---|---|
| Device name | Stent, Central Venous |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QKJ devices
openFDA lists no recalls for product code QKJ.
Frequently asked questions
What is FDA product code QKJ?
QKJ is the FDA product code for stent, central venous. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is QKJ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QKJ
- Run a recall and safety report across every QKJ manufacturer
- Watch product code QKJ 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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