The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Wallstent Rp Endoprosthesis Tracheobronchial, Wallstent Endoprosthesis Tracheobronchial.
| Device ID | K152842 |
| 510k Number | K152842 |
| Device Name: | WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Carah Kucharski |
| Correspondent | Carah Kucharski BOSTON SCIENTIFIC CORPORATION ONE SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-29 |
| Decision Date | 2016-05-19 |
| Summary: | summary |