The following data is part of a premarket notification filed by Micro-tech (nanjing) Co., Ltd. with the FDA for Through The Scope Tracheal Stent System.
| Device ID | K220424 |
| 510k Number | K220424 |
| Device Name: | Through The Scope Tracheal Stent System |
| 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 | 2022-02-14 |
| Decision Date | 2022-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06932503581660 | K220424 | 000 |
| 06932503581516 | K220424 | 000 |
| 06932503581523 | K220424 | 000 |
| 06932503581530 | K220424 | 000 |
| 06932503581547 | K220424 | 000 |
| 06932503581554 | K220424 | 000 |
| 06932503581561 | K220424 | 000 |
| 06932503581578 | K220424 | 000 |
| 06932503581585 | K220424 | 000 |
| 06932503581592 | K220424 | 000 |
| 06932503581608 | K220424 | 000 |
| 06932503581615 | K220424 | 000 |
| 06932503581622 | K220424 | 000 |
| 06932503581639 | K220424 | 000 |
| 06932503581646 | K220424 | 000 |
| 06932503581653 | K220424 | 000 |
| 06932503581509 | K220424 | 000 |