The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Wallstent Transhepatic Biliary Endoprosthesis.
| Device ID | K964119 |
| 510k Number | K964119 |
| Device Name: | WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Contact | Cathy Yohnk |
| Correspondent | Cathy Yohnk BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-15 |
| Decision Date | 1997-04-28 |
| Summary: | summary |