510(k) K252812 · KRD Device, Vascular, For Promoting Embolization
UniPearls® Embolic Microspheres
| Applicant | Suzhou Haowei Medical Technology Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Jul 31, 2026 |
| Received | Sep 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252812
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.