The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Wallstent(r) Tracheobronchial Endoprosthesis.
| Device ID | K945494 |
| 510k Number | K945494 |
| Device Name: | WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS |
| Classification | Prosthesis, Tracheal, Expandable |
| 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 | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-08 |
| Decision Date | 1995-03-03 |
| Summary: | summary |