De Novo
DEN160043: Sentinel Cerebral Protection System
FDA De Novo · claret medical, inc. · decided Jun 1, 2017
Key facts
| De Novo number | DEN160043 |
|---|---|
| Device name | Sentinel Cerebral Protection System |
| Applicant | claret medical, inc. |
| Product code | PUM |
| Date received | Sep 20, 2016 |
| Decision date | Jun 1, 2017 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Cardiovascular |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- None UDI device identifiers (GUDID)
- 100–999 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: