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
| Country | Makers |
|---|---|
| United States | 16 |
| Costa Rica | 2 |
| China | 2 |
| Mexico | 2 |
| Netherlands | 2 |
| Dominican Republic | 1 |
| Canada | 1 |
| Ireland | 1 |
| Malaysia | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 6 | December 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG | HAINA San Cristobal, Dominican Republic | Manufacturer | 6 | December 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| Opsens Inc. | Quebec City, Canada | Manufacturer | 5 | January 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical, Cardiology Division, Inc. | Plymouth, MN, United States | Specification developer | 4 | March 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| Millar LLC. | Houston, TX, United States | Manufacturer | 3 | March 10, 2017 | 0 | 0 | 0 | api.fda.gov |
| Acist Medical Systems, Inc. | Eden Prairie, MN, United States | Manufacturer | 2 | July 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Westford, MA, United States | Specification developer | 1 | March 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| Abbott Vascular | El Coyol Alajuela, Costa Rica | Exporter to the US, Manufacturer | 1 | March 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Maple Grove, MN, United States | Manufacturer | 1 | December 23, 2019 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 1 | December 23, 2019 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 1 | December 23, 2019 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences Technology Sarl | Anasco, PR, United States | Manufacturer | 1 | September 3, 2014 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Saint Paul, MN, United States | Manufacturer | 1 | March 2, 2012 | 0 | 0 | 0 | api.fda.gov |
| Zurich Medical Inc | Plymouth, MN, United States | Manufacturer | 1 | August 14, 2019 | 0 | 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 | |
| Beijing Bywave Sensing Medical Technology Co., Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CD Leycom | Hengelo Overijssel, Netherlands | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardiva Medical, Inc. | Guaymas Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EPIC MedTec OEM Catheter & Wire LLC | Plymouth, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Freudenberg Medical, LLC | Jeffersonville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metal Craft Machine & Engineering, Inc. | Elk River, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverside Machine & Engineering, Inc. | Eau Claire, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Supercomal Medical Products, Sdn Bhd | SUNGAI PETANI Kedah, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unitron Group BV | IJzendijke Zeeland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volcano Corporation | Rancho Cordova, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volcano Corporation | San Diego, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Volcano Corporation by Volcarica S.R.L. | Coyol Alajuela, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.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.