The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Ultraflex Tracheobronchial Covered Stent System.
| Device ID | K141584 |
| 510k Number | K141584 |
| Device Name: | ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Thomas Hirte |
| Correspondent | Thomas Hirte Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-13 |
| Decision Date | 2014-10-16 |
| Summary: | summary |