510(k) K231538 ยท MCW Catheter, Peripheral, Atherectomy
FreedomFlow Orbital Circumferential Atherectomy System
| Applicant | Cardio Flow Inc.,, Blaine MN, US |
| Decision | Substantially Equivalent, Sep 27, 2023 |
| Received | May 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231538
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.