De Novo
DEN190038: Surfacer Inside-Out Access Catheter System
FDA De Novo · bluegrass vascular technologies, inc. · decided Feb 10, 2020
Key facts
| De Novo number | DEN190038 |
|---|---|
| Device name | Surfacer Inside-Out Access Catheter System |
| Applicant | bluegrass vascular technologies, inc. |
| Product code | QJH |
| Date received | Aug 15, 2019 |
| Decision date | Feb 10, 2020 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Cardiovascular |
| FEI number | 3009589269 |
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: