Medivalve, Ltd.
Country not established
- Devices
- 1
What Medivalve, Ltd. makes
Medivalve, Ltd. manufactures the Medivalve ACWire, a device designed for transcatheter aortic valve replacement (TAVR) procedures, intended to facilitate valve deployment and stabilization within the aortic annulus.
The Medivalve ACWire is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Medivalve Acwire Ref K132545
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medivalve, Ltd. have in the registry?
The registry currently lists 1 device for Medivalve, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medivalve, Ltd.'s devices?
Among its 1 most recently registered device, Medivalve, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Medivalve, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Medivalve, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medivalve, Ltd. in the registry?
The most recently registered devices listed for Medivalve, Ltd. include MEDIVALVE ACWIRE.