The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Tracheal Stent System.
| Device ID | K202204 |
| 510k Number | K202204 |
| Device Name: | Tracheal Stent System |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road Nanjing, CN 210032 |
| Contact | Sally He |
| Correspondent | Sally He Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road Nanjing, CN 210032 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-05 |
| Decision Date | 2021-09-01 |