Medical Device Manufacturer · US , St Paul , MN

Cardiovascualr Systems, Inc. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2022

Recent clearances: Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardiovascualr Systems, Inc. Cardiovascular ✕

1 devices

1-1 of 1

Cleared Apr 27, 2022

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral...

Cardiovascular · 58d