De Novo
DEN190043: SafeBreak Vascular
FDA De Novo · site saver, inc. d/b/a lineus medical · decided May 27, 2021
Key facts
| De Novo number | DEN190043 |
|---|---|
| Device name | SafeBreak Vascular |
| Applicant | site saver, inc. d/b/a lineus medical |
| Product code | QOI |
| Date received | Sep 18, 2019 |
| Decision date | May 27, 2021 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | General Hospital |
| FEI number | 3019511659 |
At a glance
- 1–9 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: