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Data / Medical devices / Transducer, Pressure, Catheter Tip

Transducer, Pressure, Catheter Tip (DXO): 28 FDA-registered makers in 9 countries

28 establishments in 9 countries are registered with the FDA to make Transducer, Pressure, Catheter Tip (product code DXO, Class 2, 21 CFR 870.2870). 14 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 64 510(k) clearances under this code, the latest on January 16, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
DXO
Device class
2
Regulation
870.2870
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States16
Costa Rica2
China2
Mexico2
Netherlands2
Dominican Republic1
Canada1
Ireland1
Malaysia1

Makers of Transducer, Pressure, Catheter Tip

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
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer6December 22, 2022000api.fda.gov
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AGHAINA San Cristobal, Dominican RepublicManufacturer6December 22, 2022000api.fda.gov
Opsens Inc.Quebec City, CanadaManufacturer5January 16, 2026000api.fda.gov
St. Jude Medical, Cardiology Division, Inc.Plymouth, MN, United StatesSpecification developer4March 28, 2018000api.fda.gov
Millar LLC.Houston, TX, United StatesManufacturer3March 10, 2017000api.fda.gov
Acist Medical Systems, Inc.Eden Prairie, MN, United StatesManufacturer2July 17, 2024000api.fda.gov
Abbott MedicalWestford, MA, United StatesSpecification developer1March 28, 2018000api.fda.gov
Abbott VascularEl Coyol Alajuela, Costa RicaExporter to the US, Manufacturer1March 28, 2018000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer1December 23, 2019000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer1December 23, 2019000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer1December 23, 2019000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer1September 3, 2014000api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Saint Paul, MN, United StatesManufacturer1March 2, 2012000api.fda.gov
Zurich Medical IncPlymouth, MN, United StatesManufacturer1August 14, 2019000api.fda.gov
Amphenol Alden Products CompanyShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Amphenol Alden Products CompanyHermosillo Sonora, MexicoContract manufacturer0000api.fda.gov
Beijing Bywave Sensing Medical Technology Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
CD LeycomHengelo Overijssel, NetherlandsExporter to the US, Specification developer0000api.fda.gov
Cardiva Medical, Inc.Guaymas Sonora, MexicoContract manufacturer0000api.fda.gov
EPIC MedTec OEM Catheter & Wire LLCPlymouth, MN, United StatesContract manufacturer0000api.fda.gov
Freudenberg Medical, LLCJeffersonville, IN, United StatesContract manufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
Supercomal Medical Products, Sdn BhdSUNGAI PETANI Kedah, MalaysiaContract manufacturer0000api.fda.gov
Unitron Group BVIJzendijke Zeeland, NetherlandsContract manufacturer0000api.fda.gov
Volcano CorporationRancho Cordova, CA, United StatesManufacturer0000api.fda.gov
Volcano CorporationSan Diego, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Volcano Corporation by Volcarica S.R.L.Coyol Alajuela, Costa RicaManufacturer0000api.fda.gov

Updated January 16, 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.