The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Wallstent Tracheobronchial Endoprosthesis And Wallstent Tracheobronchial Endoprosthesis With Permalume Covering.
| Device ID | K980163 |
| 510k Number | K980163 |
| Device Name: | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING |
| Classification | Prosthesis, Tracheal, Expandable |
| 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 | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-16 |
| Decision Date | 1998-03-13 |
| Summary: | summary |