K230269 is an FDA 510(k) clearance for the Ultraflex™ Tracheobronchial Stent System. This device is classified as a Prosthesis, Tracheal, Expandable (Class II - Special Controls, product code JCT).
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on July 14, 2023, 164 days after receiving the submission on January 31, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 878.3720.
| 510(k) Number | K230269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2023 |
| Decision Date | July 14, 2023 |
| Days to Decision | 164 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | JCT — Prosthesis, Tracheal, Expandable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3720 |