510(k) K122380 ยท PDU Catheter For Crossing Total Occlusions
OCELOT SYSTEM
| Applicant | Avinger, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Nov 7, 2012 |
| Received | Aug 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122380
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.