Cardioinsight Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Cardioinsight Technologies, Inc. makes
Cardioinsight Technologies, Inc. manufactures electroanatomical mapping systems, including the ECVUE Mapping System and the CardioInsight Cardiac Mapping System. These devices are designed for detailed 3D mapping of cardiac electrical activity, aiding in the diagnosis and treatment of arrhythmias during electrophysiological procedures.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The portfolio is authorised for use in the United States, where the manufacturer is based.
Catalogue
ECVUE Mapping System Ref K150990
Regimes: 510(k) Registry: 510(k)CardioInsight Cardiac Mapping System Ref K162440
Regimes: 510(k) Registry: 510(k)Ecvue Mapping System Ref K140497
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardioinsight Technologies, Inc. have in the registry?
The registry currently lists 3 devices for Cardioinsight Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardioinsight Technologies, Inc.'s devices?
Among its 3 most recently registered devices, Cardioinsight Technologies, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Cardioinsight Technologies, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Cardioinsight Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardioinsight Technologies, Inc. in the registry?
The most recently registered devices listed for Cardioinsight Technologies, Inc. include ECVUE Mapping System and CardioInsight Cardiac Mapping System.