Cardiac Assist Devices, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Cardiac Assist Devices, Inc. makes
Cardiac Assist Devices, Inc. manufactures electrophysiology catheters, including the GYRO TIP EP CATHETER for cardiac mapping and ablation procedures, and the GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER (Model GTL-20E) for detailed intracardiac mapping. The company also produces the MAGNO ALARM, a device likely used for monitoring or alerting in cardiac interventions.
The company’s products are regulated under FDA’s 510(k) pathway, with devices classified as Class I and Class II. These devices are listed in the FDA’s 510(k) clearance registry, and the manufacturer operates from the United States.
Catalogue
Gyro Tip Ep Catheter Ref K955847
Regimes: 510(k) Registry: 510(k)Magno Alarm Ref K960849
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardiac Assist Devices, Inc. have in the registry?
The registry currently lists 3 devices for Cardiac Assist Devices, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiac Assist Devices, Inc.'s devices?
Among its 3 most recently registered devices, Cardiac Assist Devices, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Cardiac Assist Devices, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Cardiac Assist Devices, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiac Assist Devices, Inc. in the registry?
The most recently registered devices listed for Cardiac Assist Devices, Inc. include GYRO TIP EP CATHETER, MAGNO ALARM and GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E.