St. Jude Medical (Now Abbott Medical)
Country not established
- Devices
- 3
What St. Jude Medical (Now Abbott Medical) makes
The company manufactures intravascular ultrasound (IVUS) imaging systems, including the Ilumien Optis, Optis Integrated, and Optis Mobile, which provide real-time coronary and peripheral vascular imaging. It also produces the QUANTIEN Measurement System, a device for quantifying plaque volume and vessel dimensions in coronary arteries.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Ilumien Optis, Optis Integrated, Optis Mobile Ref K183320
Regimes: 510(k) Registry: 510(k)PressureWire X Ref K180558
Regimes: 510(k) Registry: 510(k)QUANTIEN Measurement System Ref K183099
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does St. Jude Medical (Now Abbott Medical) have in the registry?
The registry currently lists 3 devices for St. Jude Medical (Now Abbott Medical). Devices recorded under merged duplicate company entries are counted once.
Which registries list St. Jude Medical (Now Abbott Medical)'s devices?
Among its 3 most recently registered devices, St. Jude Medical (Now Abbott Medical) has devices listed in FDA 510(k) (3 devices).
What risk classes do St. Jude Medical (Now Abbott Medical)'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for St. Jude Medical (Now Abbott Medical)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from St. Jude Medical (Now Abbott Medical) in the registry?
The most recently registered devices listed for St. Jude Medical (Now Abbott Medical) include Ilumien Optis, Optis Integrated, Optis Mobile, PressureWire X and QUANTIEN Measurement System.