510(k) DEN230019
- Device
- 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
- 510(k) number
- DEN230019
- Product code
- QXH
- Decision
- Unknown (DENG)
- Decision date
- 2023-08-18
- Date received
- 2023-03-27
- Regulation
- 876.5016
- Classification name
- Gallbladder Drainage Stent And Delivery System
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Alexis Erazo
- Address
- 100 Boston Scientific Way Marlboro MA US 01752 01752
FDA Registration Numbers
- 3003902943
Source Documents
510(k) summary PDF not indicated by FDA