Cardio-Optics, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Cardio-Optics, Inc. makes
Cardio-Optics, Inc. manufactures the CardioOptics Augmentative Cardiac Optical Imaging System, a device used for real-time visualization of coronary blood flow and myocardial perfusion. The company also produces the Coronary Sinus Access Kit (Model KCS8F-01), designed to assist in catheter placement within the coronary sinus for diagnostic or therapeutic procedures.
The company’s devices are classified under FDA Class II and are listed in the FDA’s 510(k) registry. Cardio-Optics, Inc. is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Coronary Sinus Access Kit, Model KCS8F-01 Ref K050808
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardio-Optics, Inc. have in the registry?
The registry currently lists 2 devices for Cardio-Optics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardio-Optics, Inc.'s devices?
Among its 2 most recently registered devices, Cardio-Optics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Cardio-Optics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cardio-Optics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardio-Optics, Inc. in the registry?
The most recently registered devices listed for Cardio-Optics, Inc. include CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM and CORONARY SINUS ACCESS KIT, MODEL KCS8F-01.