510(k) K162326 ยท MCW Catheter, Peripheral, Atherectomy
Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
| Applicant | Avinger, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Oct 18, 2016 |
| Received | Aug 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162326
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.