K212403 is an FDA 510(k) clearance for the Tracheal Stent System (Y-Shaped). This device is classified as a Prosthesis, Tracheal, Expandable (Class II - Special Controls, product code JCT).
Submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on October 30, 2021, 89 days after receiving the submission on August 2, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 878.3720.
| 510(k) Number | K212403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2021 |
| Decision Date | October 30, 2021 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| 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 |