Cardiovascular Systems Incorporated
United Statesfrom the FDA registration address FDA establishment FEI 3004742232
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3004742232
- Address
- 1225 Old Highway 8 NW, Saint Paul, MN, 55112
Frequently asked questions
How many devices does Cardiovascular Systems Incorporated have in the registry?
The registry currently lists 2 devices for Cardiovascular Systems Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiovascular Systems Incorporated's devices?
Among its 2 most recently registered devices, Cardiovascular Systems Incorporated has devices listed in FDA 510(k) (2 devices).
What risk classes do Cardiovascular Systems Incorporated's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cardiovascular Systems Incorporated's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiovascular Systems Incorporated in the registry?
The most recently registered devices listed for Cardiovascular Systems Incorporated include ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS and DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM.