510(k) K183615 ยท PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
| Applicant | Avenu Medical, Inc., San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Jan 25, 2019 |
| Received | Dec 26, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183615
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.