510(k) K260351 · HCG Device, Neurovascular Embolization
Numen Helia Coil Embolization System; NumenFR Detachment System
| Applicant | MicroPort NeuroTech (Shanghai) Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, May 20, 2026 |
| Received | Feb 3, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260351
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.