The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Ultraflex Tracheobronchial Stent System- Sterile Uncovered.
| Device ID | K121048 |
| 510k Number | K121048 |
| Device Name: | ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | BOSTON SCIENTIFIC CORP. 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Janis F Taranto |
| Correspondent | Janis F Taranto BOSTON SCIENTIFIC CORP. 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 | 2012-04-06 |
| Decision Date | 2012-08-03 |
| Summary: | summary |