510(k) K153102 ยท KRD Device, Vascular, For Promoting Embolization
QuadraSphere Microspheres
| Applicant | Biosphere Medical, S.A., Roissy-En-France, FR |
| Decision | Substantially Equivalent, Nov 23, 2015 |
| Received | Oct 26, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153102
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.