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 |