Data / Medical devices / Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter (OAD): 38 FDA-registered makers in 8 countries

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

38 establishments in 8 countries are registered with the FDA to make Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter (product code OAD, Class 3). 15 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 11 recall events (1 Class I). FDA data exported November 3, 2026.

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Product code: OAD
Device class: 3
Medical specialty: Unknown
Life sustaining or supporting: Yes

Makers by country

Country	Makers
United States	19
Mexico	8
Costa Rica	3
Ireland	2
China	2
Israel	2
Germany	1
Canada	1

Makers of Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

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	PMA approvals	Recall events	Source
Irvine Biomedical. Inc.	Irvine, CA, United States	Manufacturer, Manufacturer for export, Specification developer	3	0	api.fda.gov
St. Jude Medical	Roseville, MN, United States	Manufacturer, Manufacturer for export	3	0	api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.	Saint Paul, MN, United States	Manufacturer, Manufacturer for export, Specification developer	3	0	api.fda.gov
St. Jude Medical, Cardiology Division, Inc.	Plymouth, MN, United States	Complaint file establishment, Manufacturer, Specification developer	3	2	api.fda.gov
Biosense Webster, Inc.	Irvine, CA, United States	Complaint file establishment, Specification developer	2	0	api.fda.gov
Boston Scientific Corporation	La Aurora Heredia, Costa Rica	Manufacturer	2	1	api.fda.gov
Boston Scientific Corporation	Saint Paul, MN, United States	Complaint file establishment, Manufacturer, Specification developer	2	0	api.fda.gov
Boston Scientific Corporation	Coventry, RI, United States	Manufacturer	2	0	api.fda.gov
Boston Scientific Corporation	Waltham, MA, United States	Specification developer	2	0	api.fda.gov
Boston Scientific Limited	GALWAY Galway(County), Ireland	Manufacturer	2	0	api.fda.gov
Cordis de Mexico, SA de CV	JUAREZ Chihuahua, Mexico	Manufacturer	2	0	api.fda.gov
Stockert GMBH	FREIBURG Baden-Wurttemberg, Germany	Manufacturer	2	0	api.fda.gov
Abbott Medical Costa Rica Ltda.	El Coyol Alajuela, Costa Rica	Manufacturer	1	0	api.fda.gov
Boston Scientific Corporation	El Coyol Alajuela, Costa Rica	Manufacturer	1	0	api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.	Minnetonka, MN, United States	Manufacturer	1	0	api.fda.gov
Amphenol Alden Products Company	Shenzhen Guangdong, China	Contract manufacturer	0	0	api.fda.gov
Amphenol Alden Products Company	Hermosillo Sonora, Mexico	Contract manufacturer	0	0	api.fda.gov
Amphenol DC Electronics	San Jose, CA, United States	Contract manufacturer	0	0	api.fda.gov
Armm, Inc.	Huntington Beach, CA, United States	Contract manufacturer, Contract sterilizer	0	0	api.fda.gov
ATL Technology DG,Ltd.	Dongguan Guangdong, China	Contract manufacturer	0	0	api.fda.gov
AvailMed S.A.De C.V.	Tijuana Baja California, Mexico	Contract manufacturer	0	0	api.fda.gov
Carrio Cabling Corporation	Colorado Springs, CO, United States	Contract manufacturer	0	0	api.fda.gov
CEA Medical Manufacturing, Inc.	Colorado Springs, CO, United States	Contract manufacturer	0	0	api.fda.gov
Creation Technologies Ltd	Burnaby British Columbia, Canada	Contract manufacturer	0	0	api.fda.gov
Foxconn Baja California S.A De C.V.	tijuana Baja California, Mexico	Contract manufacturer	0	0	api.fda.gov
Flextronics (Israel) LTD	Migdal Haemek Northern, Israel	Contract manufacturer	0	0	api.fda.gov
Linemaster Switch Corp.	Woodstock, CT, United States	Contract manufacturer	0	0	api.fda.gov
Medtronic Ireland	GALWAY Galway(County), Ireland	Manufacturer	0	0	api.fda.gov
Medtronic, Inc.	Mounds View, MN, United States	Specification developer	0	1	api.fda.gov
Medtronic, Inc.	Billerica, MA, United States	Manufacturer	0	0	api.fda.gov
Merit Medical Systems, Inc.	South Jordan, UT, United States	Contract manufacturer	0	0	api.fda.gov
Molex S.A. De C.V.	Nogales Sonora, Mexico	Contract manufacturer	0	0	api.fda.gov
NPA de Mexico S.de R.L. de C.V.	Tijuana Baja California, Mexico	Contract manufacturer	0	0	api.fda.gov
Plexus Corp.	Buffalo Grove, IL, United States	Contract manufacturer	0	0	api.fda.gov
Plexus Electronica S. de R.L. de C.V..	Zapopan Jalisco, Mexico	Contract manufacturer	0	0	api.fda.gov
Sanmina- Sci Israel Medical Systems Ltd.	Maalot-Tarshiha Northern, Israel	Contract manufacturer	0	0	api.fda.gov
Stellartech Research Corp.	Milpitas, CA, United States	Contract manufacturer	0	0	api.fda.gov
Venusa de Mexico S. de R.L de C.V	CIUDAD JUAREZ Chihuahua, Mexico	Contract manufacturer	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.