Tracheal Stent System (Y-Shaped)

Prosthesis, Tracheal, Expandable

Micro-Tech (Nanjing) Co., Ltd.

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).

Pre-market Notification Details

Device IDK212403
510k NumberK212403
Device Name:Tracheal Stent System (Y-Shaped)
ClassificationProsthesis, Tracheal, Expandable
Applicant Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone Nanjing,  CN 210032
ContactSally He
CorrespondentSally He
Micro-Tech (Nanjing) Co., Ltd. No.10 Gaoke Third Road, Nanjing National Hi-tech Industrial Development Zone Nanjing,  CN 210032
Product CodeJCT  
CFR Regulation Number878.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-02
Decision Date2021-10-30

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