Cardiovascular Systems Incorporated is one of 5153 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Cardiovascular Systems Incorporated - FDA 510(k) Cleared Devices
2
Total
2
Cleared
0
Denied
Cardiovascular Systems Incorporated has 2 FDA 510(k) cleared medical devices. Based in Stoughton, US.
Historical record: 2 cleared submissions from 2005 to 2013. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Cardiovascular Systems Incorporated Filter by specialty or product code using the sidebar.
Cardiovascular Systems Incorporated — FDA 510(k) Products and Clearance History
2 devices
Cleared
Nov 22, 2013
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Cardiovascular
16d
Cleared
Jan 31, 2005
ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
Cardiovascular
229d