510(k) K182397 ยท MCW Catheter, Peripheral, Atherectomy
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
| Applicant | Cardiovascular Systems, Inc., St.Paul MN, US |
| Decision | Substantially Equivalent, Dec 13, 2018 |
| Received | Sep 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182397
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.