Medical Device Manufacturer · US , Stoughton , WI

Cardiovascular Systems Incorporated - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2005

Recent clearances: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS

View 2 510(k) Devices ↓
2
Total
2
Cleared
0
Denied

FDA 510(k) Regulatory Record - Cardiovascular Systems Incorporated Cardiovascular ✕

2 devices
1-2 of 2
Cleared Nov 22, 2013
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
K133399 · MCW
Cardiovascular · 16d
Cleared Jan 31, 2005
ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
K041630 · MCW
Cardiovascular · 229d
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