510(k) K172386 ยท MCW Catheter, Peripheral, Atherectomy
1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Phoenix Atherectomy System
| Applicant | Volcano Atheromed, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, Aug 24, 2017 |
| Received | Aug 8, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K172386
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.