The following data is part of a premarket notification filed by Boston Scientific Scimed, Inc. with the FDA for Wallgraft Tracheobronchial Endoprothesis With Unistep Plus Delivery System.
| Device ID | K021901 |
| 510k Number | K021901 |
| Device Name: | WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Contact | Sherry L Sparrow |
| Correspondent | Sherry L Sparrow BOSTON SCIENTIFIC SCIMED, INC. ONE SCIMED PLACE Maple Grove, MN 55311 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-10 |
| Decision Date | 2002-07-09 |
| Summary: | summary |