510(k) K133566 ยท MCW Catheter, Peripheral, Atherectomy
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Substantially Equivalent, Dec 20, 2013 |
| Received | Nov 20, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133566
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.