510(k) K170792 ยท MCW Catheter, Peripheral, Atherectomy
Diamondback 360 Peripheral Orbital Atherectomy System
| Applicant | Cardiovascular Systems, Inc., St.Paul MN, US |
| Decision | Substantially Equivalent, Jun 9, 2017 |
| Received | Mar 16, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170792
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.