The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Tracheal Stent System (y-shaped).
| Device ID | K212403 |
| 510k Number | K212403 |
| Device Name: | Tracheal Stent System (Y-Shaped) |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone Nanjing, CN 210032 |
| Contact | Sally He |
| Correspondent | Sally He Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone 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 | 2021-08-02 |
| Decision Date | 2021-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932503581677 | K212403 | 000 |
| 06932503581707 | K212403 | 000 |
| 06932503581714 | K212403 | 000 |
| 06932503581721 | K212403 | 000 |
| 06932503581738 | K212403 | 000 |
| 06932503581745 | K212403 | 000 |
| 06932503581752 | K212403 | 000 |
| 06932503581769 | K212403 | 000 |
| 06932503581776 | K212403 | 000 |
| 06932503581783 | K212403 | 000 |
| 06932503581790 | K212403 | 000 |
| 06932503581806 | K212403 | 000 |
| 06932503581813 | K212403 | 000 |
| 06932503581820 | K212403 | 000 |
| 06932503581837 | K212403 | 000 |
| 06932503581844 | K212403 | 000 |
| 06932503581851 | K212403 | 000 |
| 06932503581684 | K212403 | 000 |
| 06932503581691 | K212403 | 000 |