510(k) K190155 ยท IYE Accelerator, Linear, Medical
FibermarX Radiopaque Tissue Marker
| Applicant | Viscus Biologics, LLC, Cleveland OH, US |
| Decision | Substantially Equivalent, Feb 27, 2019 |
| Received | Jan 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190155
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.