De Novo
DEN180058: t:slim X2 insulin pump with interoperable technology
FDA De Novo · tandem diabetes care, inc. · decided Feb 14, 2019
Key facts
| De Novo number | DEN180058 |
|---|---|
| Device name | t:slim X2 insulin pump with interoperable technology |
| Applicant | tandem diabetes care, inc. |
| Product code | QFG |
| Date received | Oct 29, 2018 |
| Decision date | Feb 14, 2019 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Clinical Chemistry |
| FEI number | 3013756811 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- 10–99 UDI device identifiers (GUDID)
- 1,000+ 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: