FDA 510(k) Applications Submitted by Cardiovascular Systems Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K210282 |
02/01/2021 |
WIRION Embolic Protection System |
Cardiovascular Systems Inc. |
| K152694 |
09/21/2015 |
Diamondback 360 Peripheral Orbital Atherectomy System |
Cardiovascular Systems Inc. |
| K210586 |
02/26/2021 |
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system |
Cardiovascular Systems Inc. |
| K190634 |
03/12/2019 |
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System |
Cardiovascular Systems Inc. |
| K182397 |
09/04/2018 |
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series |
Cardiovascular Systems Inc. |
| K203008 |
10/01/2020 |
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System |
Cardiovascular Systems Inc. |
| K220109 |
01/13/2022 |
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System |
Cardiovascular Systems Inc. |
| K180416 |
02/15/2018 |
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System |
Cardiovascular Systems Inc. |
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