The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Wallstent Tracheobronchial Prosthesis Modification.
| Device ID | K934116 |
| 510k Number | K934116 |
| Device Name: | WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Contact | Amy Peterson |
| Correspondent | Amy Peterson 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 | 1993-08-25 |
| Decision Date | 1994-06-02 |