510(k) K180102 ยท NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Embozene Color-Advanced Microspheres
| Applicant | Boston Scientific, Maple Grove MN, US |
| Decision | Substantially Equivalent, Apr 19, 2018 |
| Received | Jan 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180102
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.