Cardiovascular Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System, ViperCross Support Catheters, Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
26
Total
26
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cardiovascular Systems, Inc. Cardiovascular ✕
26 devices
Cleared
Mar 01, 2022
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360...
Cardiovascular
47d
Cleared
Sep 24, 2021
ViperCross Support Catheters
Cardiovascular
28d
Cleared
Sep 14, 2021
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth...
Cardiovascular
200d
Cleared
Aug 26, 2021
ViperCross Support Catheters
Cardiovascular
122d
Cleared
May 26, 2021
ViperCath XC Peripheral Exchange Catheter
Cardiovascular
30d
Cleared
Mar 03, 2021
WIRION Embolic Protection System
Cardiovascular
30d
Cleared
Nov 19, 2020
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360...
Cardiovascular
49d
Cleared
Mar 18, 2020
WIRION
Cardiovascular
51d
Cleared
Jul 02, 2019
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral...
Cardiovascular
112d
Cleared
Dec 29, 2018
ViperCath XC Peripheral Exchange Catheter
Cardiovascular
60d
Cleared
Dec 13, 2018
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
Cardiovascular
100d
Cleared
Apr 17, 2018
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy...
Cardiovascular
61d