510(k) K180904 ยท MJN Catheter, Intravascular Occluding, Temporary
Sniper Infusion Catheter with Balloon Occlusion
| Applicant | Embolx, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 8, 2018 |
| Received | Apr 6, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180904
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.