510(k) K233483 ยท MCW Catheter, Peripheral, Atherectomy
FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)
| Applicant | Cardio Flow Inc.,, Blaine MN, US |
| Decision | Substantially Equivalent, Feb 15, 2024 |
| Received | Oct 27, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233483
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.