Medtronic Cardiac Surgery
Country not established
- Devices
- 4
What Medtronic Cardiac Surgery makes
The company manufactures venous reservoir bags in volumes of 800 mL and 1600 mL, including versions with a Cortiva BioActive Surface coating, used in cardiac surgery procedures. It also produces the 4EDTRONIC HALL prosthetic heart valve, designed for replacement in heart valve surgery.
These devices are regulated under FDA pathways, with the venous reservoir bags classified as Class II and the prosthetic heart valve as Class III. Authorisation for these products is obtained through the FDA’s 510(k) and PMA processes, and the company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Cardiotherm Blood Cardioplegia Systems Ref K960755
Regimes: 510(k) Registry: 510(k)Medtronic Overpressure/Vacuum Relief Valve Ref K953564
Regimes: 510(k) Registry: 510(k)4EDTRONIC(R) Hall Prosthetic Heart Valve Ref P790018
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Medtronic Cardiac Surgery have in the registry?
The registry currently lists 4 devices for Medtronic Cardiac Surgery. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtronic Cardiac Surgery's devices?
Among its 4 most recently registered devices, Medtronic Cardiac Surgery has devices listed in FDA 510(k) (3 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Medtronic Cardiac Surgery's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Medtronic Cardiac Surgery's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Medtronic Cardiac Surgery in the registry?
The most recently registered devices listed for Medtronic Cardiac Surgery include MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL, CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS, MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE and 4EDTRONIC(R) HALL PROSTHETIC HEART VALVE.