510(k) K210562 ยท KRD Device, Vascular, For Promoting Embolization
HRSpheres Narrow-Size Embolic Microspheres
| Applicant | Suzhou Hengrui Hongyuan Medical Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Oct 1, 2021 |
| Received | Feb 25, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210562
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.