De Novo
DEN230019: AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent)
FDA De Novo · boston scientific corporation · decided Aug 18, 2023
Key facts
| De Novo number | DEN230019 |
|---|---|
| Device name | AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) |
| Applicant | boston scientific corporation |
| Product code | QXH |
| Date received | Mar 27, 2023 |
| Decision date | Aug 18, 2023 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Gastroenterology & Urology |
| FEI number | 3005099803 |
At a glance
- 1–9 Later 510(k)s citing this De Novo
- None 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: