510(k) K121774 ยท MCW Catheter, Peripheral, Atherectomy
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Substantially Equivalent, Sep 13, 2012 |
| Received | Jun 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121774
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.