Biosense, Ltd.
Country not established
- Devices
- 3
What Biosense, Ltd. makes
Biosense, Ltd. manufactures electroanatomical mapping systems, including the NOGA system for cardiac electrophysiology studies and its modified versions, as well as the MAGELLAN catheter for intracardiac navigation and ablation procedures.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. The company is based in the United States.
Catalogue
Noga Ref K960542
Regimes: 510(k) Registry: 510(k)Modification Of Noga Ref K990494
Regimes: 510(k) Registry: 510(k)Magellan Ref K961903
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biosense, Ltd. have in the registry?
The registry currently lists 3 devices for Biosense, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biosense, Ltd.'s devices?
Among its 3 most recently registered devices, Biosense, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Biosense, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Biosense, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biosense, Ltd. in the registry?
The most recently registered devices listed for Biosense, Ltd. include NOGA, MODIFICATION OF NOGA and MAGELLAN.