Celxcel Pty, Ltd.
Country not established
- Devices
- 1
What Celxcel Pty, Ltd. makes
Celxcel Pty, Ltd. manufactures CARDIOCEL, a medical device designed for cardiac applications, including procedures such as catheter ablation or structural heart interventions.
The company’s portfolio is regulated under Class II devices in the US, with products listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Cardiocel Ref K130872
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Celxcel Pty, Ltd. have in the registry?
The registry currently lists 1 device for Celxcel Pty, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Celxcel Pty, Ltd.'s devices?
Among its 1 most recently registered device, Celxcel Pty, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Celxcel Pty, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Celxcel Pty, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Celxcel Pty, Ltd. in the registry?
The most recently registered devices listed for Celxcel Pty, Ltd. include CARDIOCEL.