St. Jude Medical, Inc.-Endocardial Solutions
Country not established
- Devices
- 1
What St. Jude Medical, Inc.-Endocardial Solutions makes
The company produces modifications to the EnSite system (Model EE3000), a device used for electroanatomical mapping in cardiac electrophysiology procedures. These updates enhance the system’s ability to visualize and analyze heart chamber structures and electrical activity during ablation therapies.
The portfolio is regulated under FDA Class II devices and requires 510(k) clearance. The company is based in the United States.
Catalogue
Modification To Ensite System, Model EE3000 Ref K060954
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does St. Jude Medical, Inc.-Endocardial Solutions have in the registry?
The registry currently lists 1 device for St. Jude Medical, Inc.-Endocardial Solutions. Devices recorded under merged duplicate company entries are counted once.
Which registries list St. Jude Medical, Inc.-Endocardial Solutions's devices?
Among its 1 most recently registered device, St. Jude Medical, Inc.-Endocardial Solutions has devices listed in FDA 510(k) (1 device).
What risk classes do St. Jude Medical, Inc.-Endocardial Solutions's devices fall under?
Among its 1 most recently registered device, the classes recorded for St. Jude Medical, Inc.-Endocardial Solutions's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from St. Jude Medical, Inc.-Endocardial Solutions in the registry?
The most recently registered devices listed for St. Jude Medical, Inc.-Endocardial Solutions include MODIFICATION TO ENSITE SYSTEM, MODEL EE3000.