The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Wallstent Endoprosthesis.
| Device ID | K982184 |
| 510k Number | K982184 |
| Device Name: | WALLSTENT ENDOPROSTHESIS |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Contact | Philip B Jarvi |
| Correspondent | Philip B Jarvi BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Product Code | JCT |
| Subsequent Product Code | ESW |
| Subsequent Product Code | FGE |
| Subsequent Product Code | MQR |
| Subsequent Product Code | MUM |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-22 |
| Decision Date | 1998-07-21 |
| Summary: | summary |