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
| Country | Makers |
|---|---|
| United States | 21 |
| Mexico | 6 |
| Costa Rica | 3 |
| Germany | 2 |
| Ireland | 2 |
| China | 2 |
| Canada | 1 |
| Dominican Republic | 1 |
| Israel | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Biosense Webster, Inc. | Irvine, CA, United States | Complaint file establishment, Specification developer | 0 | 3 | 0 | 0 | api.fda.gov | |
| Cordis de Mexico, SA de CV | JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 3 | 1 | 0 | api.fda.gov | |
| Medtronic, Inc. | Mounds View, MN, United States | Specification developer | 0 | 2 | 1 | 0 | api.fda.gov | |
| Stockert GMBH | FREIBURG Baden-Wurttemberg, Germany | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| St. Jude Medical | Roseville, MN, United States | Manufacturer, Manufacturer for export | 0 | 2 | 0 | 0 | api.fda.gov | |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Saint Paul, MN, United States | Manufacturer, Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| St. Jude Medical, Cardiology Division, Inc. | Plymouth, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | La Aurora Heredia, Costa Rica | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | El Coyol Alajuela, 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 | 0 | 0 | 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 | |
| Covidien | - Galway(County), Ireland | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Irvine Biomedical. Inc. | Irvine, CA, United States | Manufacturer, Manufacturer for export, Specification developer | 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 | 1 | 0 | api.fda.gov | |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| OSYPKA GmbH | Rheinfelden Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Stereotaxis, Inc. | Saint Louis, MO, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Minnetonka, MN, United States | Manufacturer, Manufacturer for export, Specification developer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Technical Services For Electronics, Inc. | Jackson, MN, United States | Contract manufacturer, Repackager or relabeler | 0 | 1 | 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 | |
| Amphenol DC Electronics | San Jose, CA, United States | 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 DG,Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Medical Costa Rica Ltda. | El Coyol Alajuela, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Waltham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Queensbury, NY, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carrio Cabling Corporation | Colorado Springs, CO, United States | Contract manufacturer | 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 | 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 | |
| HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linemaster Switch Corp. | Woodstock, CT, United States | 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 | |
| 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 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.