The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Wallgraft Tracheobronchial Endoprosthesis And Unistep Delivery System.
| Device ID | K000001 |
| 510k Number | K000001 |
| Device Name: | WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. 5905 NATHAN LN. Minneapolis, MN 55442 |
| Contact | Ron Bennett |
| Correspondent | Ron 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 | 2000-01-03 |
| Decision Date | 2000-06-05 |