Cardiosonix, Ltd.
IsraelFDA applicant, unverified
- Devices
- 3
What Cardiosonix, Ltd. makes
Cardiosonix, Ltd. manufactures intravascular devices, including the QUANTIX/ND, QUANTIX/OR, and QUANTIX/Vessel Stabilizer, which are designed for use in coronary artery procedures to support vessel stability and reduce complications during interventions.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Quantix/Nd Device Ref K023431
Regimes: 510(k) Registry: 510(k)Quantix Or Vessel Stabilizer Device Ref K041180
Regimes: 510(k) Registry: 510(k)Quantix/Or Device Ref K030357
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardiosonix, Ltd. have in the registry?
The registry currently lists 3 devices for Cardiosonix, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiosonix, Ltd.'s devices?
Among its 3 most recently registered devices, Cardiosonix, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Cardiosonix, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Cardiosonix, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiosonix, Ltd. in the registry?
The most recently registered devices listed for Cardiosonix, Ltd. include QUANTIX/ND DEVICE, QUANTIX OR VESSEL STABILIZER DEVICE and QUANTIX/OR DEVICE.