510(k) DEN150040
- Device
- WallFlex Biliary RX Fully Covered Stent System RMV
- Applicant
- Boston Scientific
- 510(k) number
- DEN150040
- Product code
- PNB
- Decision
- Unknown (DENG)
- Decision date
- 2016-06-03
- Date received
- 2015-08-28
- Regulation
- 876.5011
- Classification name
- Biliary Stent System For Benign Strictures
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- THOMAS HIRTE
- Address
- 100 Boston Scientific Way Marlboro MA US 01752 01752
FDA Registration Numbers#
- 3002807314
- 9681260
- 1000121056
- 3010273872
- 3005099803
Source Documents#
510(k) summary PDF not indicated by FDA