510(k) K242947 · MCW Catheter, Peripheral, Atherectomy
FreedomFlow Orbital Circumferential Atherectomy System
| Applicant | Cardio Flow Inc.,, Blaine MN, US |
| Decision | Substantially Equivalent, Nov 5, 2024 |
| Received | Sep 25, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K242947
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.