Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series — Cardiovascular Systems, Inc. (510(k) K182397)
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series — Cardiovascular Systems, Inc. (510(k) K182397) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series; Applicant: Cardiovascular Systems,
| Device name | Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series |
|---|---|
| Applicant | Cardiovascular Systems, Inc. |
| Clearance track | 510(k) |
| Submission number | K182397 |
| Decision | Substantially Equivalent |
| Decision date | 2018-12-13 |
| Date received | 2018-09-04 |
| Product code | MCW |
| Device class | 2 |
| Medical specialty | Cardiovascular |
| Applicant location | MN, US |
| Source | openFDA device |
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