FDA product code QYI: Ablation Catheter, Renal Denervation
QYI is the FDA product code for ablation catheter, renal denervation. It is a Class III device, reviewed by the Cardiovascular panel. Devices under QYI reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 2 recalls for QYI devices, 2 initiated in the last five years.
Definition
For denervating the renal nerves to lower blood pressure
Classification
| Field | Value |
|---|---|
| Device name | Ablation Catheter, Renal Denervation |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for QYI devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-01-29.
| Year | Recalls |
|---|---|
| 2026 | 2 |
Frequently asked questions
What is FDA product code QYI?
QYI is the FDA product code for ablation catheter, renal denervation. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is QYI?
Class III. Typical premarket route: PMA.
Have QYI devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2026-01-29.
Next steps
- Run an FDA pathway report with predicate devices for product code QYI
- Run a recall and safety report across every QYI manufacturer
- Watch product code QYI 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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