510(k) K140185 ยท PDU Catheter For Crossing Total Occlusions
OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE
| Applicant | Avinger, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, May 1, 2014 |
| Received | Jan 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140185
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.