510(k) K210586 ยท MCW Catheter, Peripheral, Atherectomy
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
| Applicant | Cardiovascular Systems, Inc., St.Paul MN, US |
| Decision | Substantially Equivalent, Sep 14, 2021 |
| Received | Feb 26, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210586
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.