FDA product code OAD: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
OAD is the FDA product code for catheter, percutaneous, cardiac ablation, for treatment of atrial flutter. It is a Class III device, reviewed by the Cardiovascular panel. Devices under OAD reach the market by PMA; FDA lists no cleared 510(k)s for it. 9 PMA applications cite this product code. FDA has posted 22 recalls for OAD devices, 2 initiated in the last five years.
Definition
For the treatment of atrial flutter.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Life-sustaining or supporting | Yes |
Recalls for OAD devices
22 product recalls in 11 recall events; 2 initiated in the last five years and 6 still open. Most recent: 2026-03-11.
| Year | Recalls |
|---|---|
| 2018 | 4 |
| 2022 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code OAD?
OAD is the FDA product code for catheter, percutaneous, cardiac ablation, for treatment of atrial flutter. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is OAD?
Class III. Typical premarket route: PMA.
Have OAD devices been recalled?
Yes: 22 product recalls across 11 recall events; the most recent began 2026-03-11.
Next steps
- Run an FDA pathway report with predicate devices for product code OAD
- Run a recall and safety report across every OAD manufacturer
- Watch product code OAD 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.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times