510(k) K191419 ยท MCW Catheter, Peripheral, Atherectomy
Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire
| Applicant | Rex Medical, L.P., Conshohocken PA, US |
| Decision | Substantially Equivalent, Sep 12, 2019 |
| Received | May 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191419
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.