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Data / Medical devices / Cardiac Ablation Percutaneous Catheter

Cardiac Ablation Percutaneous Catheter (LPB): 39 FDA-registered makers in 9 countries

39 establishments in 9 countries are registered with the FDA to make Cardiac Ablation Percutaneous Catheter (product code LPB, Class 3). 21 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 14 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
LPB
Device class
3
Medical specialty
Unknown

Makers by country

CountryMakers
United States21
Mexico6
Costa Rica3
Germany2
Ireland2
China2
Canada1
Dominican Republic1
Israel1

Makers of Cardiac Ablation Percutaneous Catheter

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Biosense Webster, Inc.Irvine, CA, United StatesComplaint file establishment, Specification developer0300api.fda.gov
Cordis de Mexico, SA de CVJUAREZ Chihuahua, MexicoManufacturer0310api.fda.gov
Medtronic, Inc.Mounds View, MN, United StatesSpecification developer0210api.fda.gov
Stockert GMBHFREIBURG Baden-Wurttemberg, GermanyManufacturer0200api.fda.gov
St. Jude MedicalRoseville, MN, United StatesManufacturer, Manufacturer for export0200api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Saint Paul, MN, United StatesManufacturer, Specification developer0200api.fda.gov
St. Jude Medical, Cardiology Division, Inc.Plymouth, MN, United StatesComplaint file establishment, Manufacturer, Specification developer0200api.fda.gov
Boston Scientific CorporationLa Aurora Heredia, Costa RicaManufacturer0100api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer0100api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer, Specification developer0100api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0100api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer0100api.fda.gov
Covidien- Galway(County), IrelandManufacturer0100api.fda.gov
Irvine Biomedical. Inc.Irvine, CA, United StatesManufacturer, Manufacturer for export, Specification developer0100api.fda.gov
Medtronic Puerto Rico Operations Co., VillalbaVillalba, PR, United StatesManufacturer0100api.fda.gov
Medtronic CryoCath LPPointe-Claire Quebec, CanadaManufacturer0110api.fda.gov
Medtronic Mexico S. de R.L. de CVTijuana Baja California, MexicoManufacturer0100api.fda.gov
OSYPKA GmbHRheinfelden Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer0100api.fda.gov
Stereotaxis, Inc.Saint Louis, MO, United StatesSpecification developer0100api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Minnetonka, MN, United StatesManufacturer, Manufacturer for export, Specification developer0110api.fda.gov
Technical Services For Electronics, Inc.Jackson, MN, United StatesContract manufacturer, Repackager or relabeler0100api.fda.gov
Amphenol Alden Products CompanyShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Amphenol Alden Products CompanyHermosillo Sonora, MexicoContract manufacturer0000api.fda.gov
Amphenol DC ElectronicsSan Jose, CA, United StatesContract manufacturer0000api.fda.gov
Armm, Inc.Huntington Beach, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
ATL Technology DG,Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Abbott Medical Costa Rica Ltda.El Coyol Alajuela, Costa RicaManufacturer0000api.fda.gov
Boston Scientific CorporationWaltham, MA, United StatesSpecification developer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Carrio Cabling CorporationColorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
CEA Global Dominicana d.b.a. Nissha Medical TechnologiesSan Pedro de Macoris, Dominican RepublicContract manufacturer0000api.fda.gov
CEA Medical Manufacturing, Inc.Colorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Foxconn Baja California S.A De C.V.tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Flextronics (Israel) LTDMigdal Haemek Northern, IsraelContract manufacturer0000api.fda.gov
HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Linemaster Switch Corp.Woodstock, CT, United StatesContract manufacturer0000api.fda.gov
Plexus Corp.Buffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
Stellartech Research Corp.Milpitas, CA, United StatesContract manufacturer0000api.fda.gov
Venusa de Mexico S. de R.L de C.VCIUDAD JUAREZ Chihuahua, MexicoContract manufacturer0000api.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.