510(k) K261715 ยท PUM Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Emboliner Embolic Protection System (EPC-03)
| Applicant | Emboline, Inc., Santa Cruz CA, US |
| Decision | Substantially Equivalent, Sep 8, 2026 |
| Received | May 22, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261715
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.