Tenerco, Inc.
Country not established
- Devices
- 1
What Tenerco, Inc. makes
Tenerco, Inc. manufactures the HELICA TC, a transcatheter heart valve designed for structural heart disease interventions. This device is intended for percutaneous placement within the aorta or pulmonary position to treat conditions such as aortic stenosis or pulmonary valve dysfunction.
The HELICA TC is classified as a Class II medical device under FDA regulations and has undergone 510(k) clearance. The company operates from the United States, where its products are registered and monitored for compliance with U.S. medical device standards.
Catalogue
Helica Tc Ref K972267
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Tenerco, Inc. have in the registry?
The registry currently lists 1 device for Tenerco, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tenerco, Inc.'s devices?
Among its 1 most recently registered device, Tenerco, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Tenerco, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Tenerco, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tenerco, Inc. in the registry?
The most recently registered devices listed for Tenerco, Inc. include HELICA TC.