510(k) K211344 ยท HCG Device, Neurovascular Embolization
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
| Applicant | Medos International SARL, Le Locle, CH |
| Decision | Substantially Equivalent, May 28, 2021 |
| Received | May 3, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211344
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.