510(k) K181725 ยท PQK Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access
Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
| Applicant | Avenu Medical, Inc., San Juan Capistrano CA, US |
| Decision | Substantially Equivalent, Oct 5, 2018 |
| Received | Jun 29, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181725
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.