De Novo
DEN200067: INNOVANCE VWF Ac
FDA De Novo · siemens healthcare diagnostics products gmbh · decided Sep 29, 2022
Key facts
| De Novo number | DEN200067 |
|---|---|
| Device name | INNOVANCE VWF Ac |
| Applicant | siemens healthcare diagnostics products gmbh |
| Product code | QTY |
| Date received | Oct 28, 2020 |
| Decision date | Sep 29, 2022 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Hematology |
| FEI number | 3001644026 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 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: