510(k) DEN170004 ยท PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Ellipsys Vascular Access System
| Applicant | Avenu Medical, Inc., San Juan Capistrano CA, US |
| Decision | Unknown, Jun 22, 2018 |
| Received | Jan 10, 2017 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN170004
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.