510(k) K091510
- Device
- WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K091510
- Product code
- ESW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-06-26
- Date received
- 2009-05-22
- Regulation
- 878.3610
- Classification name
- Prosthesis, Esophageal
- Medical specialty
- General & Plastic Surgery
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Marybeth Gamber
- Address
- 100 Boston Scientific Way Marlboro MA US 01752 01752
FDA Registration Numbers
- 3002807314
- 3010665433
- 3011458193
- 3010173425
- 3013337852
- 3004837686
- 3013440400
- 3012536737
- 3005580113
- 3003902943
- 3008146331
- 3001845648
- 3009906660
- 3015225571
- 3010273872
- 3000247987
- 3009526575
- 3006017180
- 1000121056
- 3015309643
- 1225687
- 1721504
- 1721676
- 3014172183
- 1724474
- 3033589330
- 3006950086
- 3005987240
- 3005099803
- 3040096051
- 9681260
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Legacy Summary
summary
FDA Review
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases