De Novo
DEN140018: ESOPHAGEAL COOLING DEVICE
FDA De Novo · advanced cooling therapy, llc · decided Jun 23, 2015
Key facts
| De Novo number | DEN140018 |
|---|---|
| Device name | ESOPHAGEAL COOLING DEVICE |
| Applicant | advanced cooling therapy, llc |
| Product code | PLA |
| Date received | May 9, 2014 |
| Decision date | Jun 23, 2015 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Cardiovascular |
| FEI number | 3010412492 |
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: