Cardiotronics Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Cardiotronics Systems, Inc. makes
Cardiotronics Systems, Inc. manufactures disposable and reusable stimulation electrodes, including radiolucent and multi-pad designs for medical procedures. Their product line includes the 700-F series, 700-MP disposable radiolucent multi-pad electrodes, 700-SP disposable stimulation electrodes, and the 700-FR radiolucent stimulation electrodes.
The company’s devices are classified under FDA Class II and Class III regulations, with submissions supported by 510(k) clearances. These products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
700-F Series Stimulation Electrodes Ref K964469
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
700-Sp Series Disposable Stimulation Electrodes Ref K971148
Regimes: 510(k) Registry: 510(k)700-Fr Series Radiolucent Stimulation Electrodes Ref K964991
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardiotronics Systems, Inc. have in the registry?
The registry currently lists 4 devices for Cardiotronics Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiotronics Systems, Inc.'s devices?
Among its 4 most recently registered devices, Cardiotronics Systems, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Cardiotronics Systems, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Cardiotronics Systems, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Cardiotronics Systems, Inc. in the registry?
The most recently registered devices listed for Cardiotronics Systems, Inc. include 700-F SERIES STIMULATION ELECTRODES, 700-MP DISPOSABLE RADIOLUCENT MULTI-PAD ELECTRODES, 700-SP SERIES DISPOSABLE STIMULATION ELECTRODES and 700-FR SERIES RADIOLUCENT STIMULATION ELECTRODES.