Data / Medical devices / Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (OAE): 46 FDA-registered makers in 11 countries
46 establishments in 11 countries are registered with the FDA to make Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (product code OAE, Class 3). 18 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 14 recall events (2 Class I). FDA data exported November 3, 2026.
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- Product code
- OAE
- Device class
- 3
- Medical specialty
- Unknown
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 23 |
| Mexico | 7 |
| Canada | 4 |
| Costa Rica | 3 |
| Ireland | 2 |
| Israel | 2 |
| China | 1 |
| Dominican Republic | 1 |
| Thailand | 1 |
| Malaysia | 1 |
| Germany | 1 |
Makers of Catheter, Percutaneous, Cardiac Ablation, 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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Medical Costa Rica Ltda. | El Coyol Alajuela, Costa Rica | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Medtronic, Inc. | Mounds View, MN, United States | Specification developer | 0 | 2 | 2 | 0 | api.fda.gov | |
| St. Jude Medical | Roseville, MN, United States | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Saint Paul, MN, United States | Manufacturer, Specification developer | 0 | 2 | 2 | 0 | api.fda.gov | |
| St. Jude Medical, Cardiology Division, Inc. | Plymouth, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 2 | 4 | 1 | api.fda.gov | |
| Biosense Webster, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | La Aurora Heredia, Costa Rica | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 1 | 1 | 1 | api.fda.gov | |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cardiofocus, Inc. | Marlborough, MA, United States | Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Cordis de Mexico, SA de CV | JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cryterion Medical Inc. | Saint Laurent Quebec, Canada | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Ireland | GALWAY Galway(County), Ireland | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Villalba | Villalba, PR, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic CryoCath LP | Pointe-Claire Quebec, Canada | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic, Inc. | Minneapolis, MN, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Access Point Technologies, Ep Inc. | Rogers, MN, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol Alden Products Company | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol Alden Products Company | Hermosillo Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Armm, Inc. | Huntington Beach, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ATL Technology CR Limitada | Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Waltham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CEA Global Dominicana d.b.a. Nissha Medical Technologies | San Pedro de Macoris, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CEA Medical Manufacturing, Inc. | Colorado Springs, CO, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| CRC Ep, Inc. | Tustin, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creation Technologies Ltd | Burnaby British Columbia, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Farapulse, Inc. | Menlo Park, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foxconn Baja California S.A De C.V. | tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics (Israel) LTD | Migdal Haemek Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KARDIUM Inc. | Burnaby British Columbia, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linemaster Switch Corp. | Woodstock, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lake Region Medical | Trenton, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic, Inc. | Billerica, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnetronix, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Molex (thailand) Ltd. | Bangpakong Chachoengsao, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NPA de Mexico S.de R.L. de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Corp. | Buffalo Grove, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Optics Corp. | Gardner, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Electronica S. de R.L. de C.V.. | Zapopan Jalisco, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plexus Manufacturing Sdn. Bhd. | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina- Sci Israel Medical Systems Ltd. | Maalot-Tarshiha Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stockert GMBH | FREIBURG Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stellartech Research Corp. | Milpitas, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Venusa de Mexico S. de R.L de C.V | CIUDAD JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.