FDA product code OCM: Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
OCM is the FDA product code for surgical cardiac ablation device, for treatment of atrial fibrillation. It is a Class III device, reviewed by the Cardiovascular panel. Devices under OCM reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Definition
Surgical cardiac ablation for the treatment of atrial fibrillation.
Classification
| Field | Value |
|---|---|
| Device name | Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for OCM devices
openFDA lists no recalls for product code OCM.
Frequently asked questions
What is FDA product code OCM?
OCM is the FDA product code for surgical cardiac ablation device, for treatment of atrial fibrillation. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is OCM?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OCM
- Run a recall and safety report across every OCM manufacturer
- Watch product code OCM 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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