De Novo
DEN190042: Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
FDA De Novo · baxter healthcare corporation · decided Aug 28, 2020
Key facts
| De Novo number | DEN190042 |
|---|---|
| Device name | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer |
| Applicant | baxter healthcare corporation |
| Product code | QAX |
| Date received | Sep 16, 2019 |
| Decision date | Aug 28, 2020 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Gastroenterology & Urology |
| FEI number | 1417572 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- None 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: