Abbott (Formerly Thoratec Corporation)
United StatesFDA applicant, unverified
- Devices
- 2
What Abbott (Formerly Thoratec Corporation) makes
Abbott manufactures the CentriMag™ Blood Pump, a temporary ventricular assist device designed for acute circulatory support in patients with severe heart failure. The company also produces associated cannula kits, including arterial and venous drainage components, for use with the CentriMag Circulatory Support System.
These devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. Abbott’s portfolio is listed in the FDA’s 510(k) database, reflecting compliance with US medical device regulations.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Abbott (Formerly Thoratec Corporation) have in the registry?
The registry currently lists 2 devices for Abbott (Formerly Thoratec Corporation). Devices recorded under merged duplicate company entries are counted once.
Which registries list Abbott (Formerly Thoratec Corporation)'s devices?
Among its 2 most recently registered devices, Abbott (Formerly Thoratec Corporation) has devices listed in FDA 510(k) (2 devices).
What risk classes do Abbott (Formerly Thoratec Corporation)'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Abbott (Formerly Thoratec Corporation)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Abbott (Formerly Thoratec Corporation) in the registry?
The most recently registered devices listed for Abbott (Formerly Thoratec Corporation) include CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System and CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit.