510(k) K180416 ยท MCW Catheter, Peripheral, Atherectomy
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
| Applicant | Cardiovascular Systems, Inc., St.Paul MN, US |
| Decision | Substantially Equivalent, Apr 17, 2018 |
| Received | Feb 15, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180416
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.