FDA product code OAE: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
OAE is the FDA product code for catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation. It is a Class III device, reviewed by the Cardiovascular panel. Devices under OAE reach the market by PMA; FDA lists no cleared 510(k)s for it. 10 PMA applications cite this product code. FDA has posted 34 recalls for OAE devices, 17 initiated in the last five years.
Definition
For the treatment of atrial fibrillation.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for OAE devices
34 product recalls in 14 recall events; 17 initiated in the last five years and 24 still open. Most recent: 2025-09-10.
| Year | Recalls |
|---|---|
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 6 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 7 |
| 2025 | 6 |
Frequently asked questions
What is FDA product code OAE?
OAE is the FDA product code for catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is OAE?
Class III. Typical premarket route: PMA.
Have OAE devices been recalled?
Yes: 34 product recalls across 14 recall events; the most recent began 2025-09-10.
Next steps
- Run an FDA pathway report with predicate devices for product code OAE
- Run a recall and safety report across every OAE manufacturer
- Watch product code OAE 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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