510(k) K171946 ยท KRD Device, Vascular, For Promoting Embolization
Gel-Bead
| Applicant | Vascular Solutions, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Oct 25, 2017 |
| Received | Jun 29, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171946
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.