510(k) K220962 ยท MCW Catheter, Peripheral, Atherectomy
ROTAPRO Rotational Atherectomy System
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Sep 6, 2022 |
| Received | Apr 1, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220962
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.