510(k) K220109 ยท MCW Catheter, Peripheral, Atherectomy
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
| Applicant | Cardiovascular Systems, Inc., St.Paul MN, US |
| Decision | Substantially Equivalent, Mar 1, 2022 |
| Received | Jan 13, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K220109
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.