The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Wallstent Biliary Endoprosthesis And Unistep Plus Delivery System.
| Device ID | K993232 |
| 510k Number | K993232 |
| Device Name: | WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Contact | Ronald W Bennett |
| Correspondent | Ronald W Bennett BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-27 |
| Decision Date | 1999-12-30 |
| Summary: | summary |