Data / Medical devices / Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation / United States

FDA-registered makers of Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation in the United States: 23 establishments

Name: FDA-registered makers of Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation in the United States
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

23 establishments in the United States are registered with the FDA to make Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (product code OAE). 10 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 3, 2026.

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Device: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Product code: OAE
Country: United States

Makers of Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation in the United States

Maker	Location	Role	PMA approvals	Recall events	Class I	Source
Medtronic, Inc.	Mounds View, MN, United States	Specification developer	2	2	0	api.fda.gov
St. Jude Medical	Roseville, MN, United States	Manufacturer	2	0	0	api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.	Saint Paul, MN, United States	Manufacturer, Specification developer	2	2	0	api.fda.gov
St. Jude Medical, Cardiology Division, Inc.	Plymouth, MN, United States	Complaint file establishment, Manufacturer, Specification developer	2	4	1	api.fda.gov
Biosense Webster, Inc.	Irvine, CA, United States	Complaint file establishment, Manufacturer, Specification developer	1	0	0	api.fda.gov
Boston Scientific Corporation	Saint Paul, MN, United States	Complaint file establishment, Manufacturer, Specification developer	1	1	1	api.fda.gov
Boston Scientific Corporation	Coventry, RI, United States	Manufacturer	1	0	0	api.fda.gov
Cardiofocus, Inc.	Marlborough, MA, United States	Manufacturer	1	1	0	api.fda.gov
Medtronic Puerto Rico Operations Co., Villalba	Villalba, PR, United States	Manufacturer	1	0	0	api.fda.gov
Medtronic, Inc.	Minneapolis, MN, United States	Manufacturer	1	0	0	api.fda.gov
Access Point Technologies, Ep Inc.	Rogers, MN, United States	Manufacturer for export	0	0	0	api.fda.gov
Armm, Inc.	Huntington Beach, CA, United States	Contract manufacturer, Contract sterilizer	0	0	0	api.fda.gov
Boston Scientific Corporation	Waltham, MA, United States	Specification developer	0	0	0	api.fda.gov
CEA Medical Manufacturing, Inc.	Colorado Springs, CO, United States	Contract manufacturer, Manufacturer for export	0	0	0	api.fda.gov
CRC Ep, Inc.	Tustin, CA, United States	Manufacturer for export	0	0	0	api.fda.gov
Farapulse, Inc.	Menlo Park, CA, United States	Manufacturer for export	0	0	0	api.fda.gov
Linemaster Switch Corp.	Woodstock, CT, United States	Contract manufacturer	0	0	0	api.fda.gov
Lake Region Medical	Trenton, GA, United States	Contract manufacturer	0	0	0	api.fda.gov
Medtronic, Inc.	Billerica, MA, United States	Manufacturer	0	0	0	api.fda.gov
Minnetronix, Inc.	Saint Paul, MN, United States	Contract manufacturer	0	0	0	api.fda.gov
Plexus Corp.	Buffalo Grove, IL, United States	Contract manufacturer	0	0	0	api.fda.gov
Precision Optics Corp.	Gardner, MA, United States	Contract manufacturer	0	0	0	api.fda.gov
Stellartech Research Corp.	Milpitas, CA, United States	Contract manufacturer	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.