510(k) K211518 ยท MCW Catheter, Peripheral, Atherectomy
2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
| Applicant | Volcano Atheromed, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, Jun 14, 2021 |
| Received | May 17, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211518
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.