510(k) K173891 ยท KRD Device, Vascular, For Promoting Embolization
Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
| Applicant | Vascular Solutions, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jan 19, 2018 |
| Received | Dec 21, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173891
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.