Data / Medical devices / Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation (OCM): 6 FDA-registered makers in 1 country
6 establishments in 1 country are registered with the FDA to make Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation (product code OCM, Class 3). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OCM
- Device class
- 3
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
Makers of Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Atricure, Inc. | Mason, OH, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Cardiofocus, Inc. | Marlborough, MA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnetronix, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stellartech Research Corp. | Milpitas, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vesta | Franklin, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xeridiem Medical Devices | Tucson, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.