K121048 is an FDA 510(k) clearance for the ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED. This device is classified as a Prosthesis, Tracheal, Expandable (Class II - Special Controls, product code JCT).
Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on August 3, 2012, 119 days after receiving the submission on April 6, 2012.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3720.
| 510(k) Number | K121048 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2012 |
| Decision Date | August 03, 2012 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | JCT — Prosthesis, Tracheal, Expandable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3720 |