De Novo
DEN170004: Ellipsys Vascular Access System
FDA De Novo · avenu medical, inc · decided Jun 22, 2018
Key facts
| De Novo number | DEN170004 |
|---|---|
| Device name | Ellipsys Vascular Access System |
| Applicant | avenu medical, inc |
| Product code | PQK |
| Date received | Jan 10, 2017 |
| Decision date | Jun 22, 2018 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Cardiovascular |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: