FDA product code QZK: Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions
QZK is the FDA product code for endovascular system for treatment of thoracoabdominal and pararenal aortic lesions. It is a Class III device, reviewed by the Cardiovascular panel. Devices under QZK reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Endovascular repair of thoracoabdominal and pararenal aortic lesions
Classification
| Field | Value |
|---|---|
| Device name | Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for QZK devices
openFDA lists no recalls for product code QZK.
Frequently asked questions
What is FDA product code QZK?
QZK is the FDA product code for endovascular system for treatment of thoracoabdominal and pararenal aortic lesions. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is QZK?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code QZK
- Run a recall and safety report across every QZK manufacturer
- Watch product code QZK 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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