AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle

Bronchoscope Accessory

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 Areustm Endobronchial Ultrasound Aspiration Needle, Tridenttm Endobronchial Ultrasound Aspiration Needle.

Pre-market Notification Details

Device IDK213060
510k NumberK213060
Device Name:AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle
ClassificationBronchoscope Accessory
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 CodeKTI  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-22
Decision Date2022-07-20

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