510(k) K240873 ยท KRD Device, Vascular, For Promoting Embolization
TEMBO Embolic System
| Applicant | Instylla, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Dec 16, 2024 |
| Received | Mar 29, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240873
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.