De Novo
DEN150049: Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm
FDA De Novo · concentric medical, inc. · decided Sep 2, 2016
Key facts
| De Novo number | DEN150049 |
|---|---|
| Device name | Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm |
| Applicant | concentric medical, inc. |
| Product code | POL |
| Date received | Oct 26, 2015 |
| Decision date | Sep 2, 2016 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Neurology |
| FEI number | 3003271051 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- None 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: