510(k) K163264 ยท MCW Catheter, Peripheral, Atherectomy
Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled
| Applicant | Avinger, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Dec 21, 2016 |
| Received | Nov 21, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163264
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.