De Novo
DEN240066: COAPTIUM Connect with TISSIUM LIGHT
FDA De Novo · tissium sa · decided Jun 17, 2025
Key facts
| De Novo number | DEN240066 |
|---|---|
| Device name | COAPTIUM Connect with TISSIUM LIGHT |
| Applicant | tissium sa |
| Product code | SFD |
| Date received | Nov 21, 2024 |
| Decision date | Jun 17, 2025 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Neurology |
| FEI number | 3021453307 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- 10–99 UDI device identifiers (GUDID)
- 1–9 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: