FDA product code QXV: Temperature Regulation Device For Esophageal Protection During Cardiac Ablation
QXV is the FDA product code for temperature regulation device for esophageal protection during cardiac ablation. It is a Class II device, regulated under 21 CFR 870.5720 and reviewed by the Cardiovascular panel. Devices under QXV reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures. The device uses temperature regulation to control the temperature of the esophagus during cardiac ablation.
Classification
| Field | Value |
|---|---|
| Device name | Temperature Regulation Device For Esophageal Protection During Cardiac Ablation |
| Device class | Class II |
| Regulation | 21 CFR 870.5720 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Recalls for QXV devices
openFDA lists no recalls for product code QXV.
Frequently asked questions
What is FDA product code QXV?
QXV is the FDA product code for temperature regulation device for esophageal protection during cardiac ablation. It is a Class II device, regulated under 21 CFR 870.5720 and reviewed by the Cardiovascular panel.
What device class is QXV?
Class II, regulation 21 CFR 870.5720. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QXV
- Run a recall and safety report across every QXV manufacturer
- Watch product code QXV 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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