Cardiovascular Systems, Inc. · Class II · Cleared Apr 17, 2018
| K-number | K180416 |
| Device name | ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System |
| Applicant | Cardiovascular Systems, Inc. |
| Product code | MCW |
| Device class | Class II |
| Decision date | Apr 17, 2018 |
| Decision | Substantially Equivalent |
| Regulation | 870.4875 |
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