510(k) K250209 ยท KRD Device, Vascular, For Promoting Embolization
Polyvinyl Alcohol Embolic Microspheres
| Applicant | Canyon Medical, Inc., Nanjing, CN |
| Decision | Substantially Equivalent, Sep 23, 2025 |
| Received | Jan 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250209
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.