BIOTEQ Drainage Catheter BT-PDS-series

Stents, Drains And Dilators For The Biliary Ducts

Bioteque Corporation

The following data is part of a premarket notification filed by Bioteque Corporation with the FDA for Bioteq Drainage Catheter Bt-pds-series.

Pre-market Notification Details

Device IDK210419
510k NumberK210419
Device Name:BIOTEQ Drainage Catheter BT-PDS-series
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant Bioteque Corporation 5F-6, No. 23, Sec. 1, Chang’an E. Rd., Zhongshan Dist. Taipei City,  TW 104
ContactStella Hsu
CorrespondentStella Hsu
Bioteque Corporation 5F-6, No. 23, Sec. 1, Chang’an E. Rd., Zhongshan Dist. Taipei City,  TW 104
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-11
Decision Date2022-04-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04046955639120 K210419 000
04046955639106 K210419 000
04046955639083 K210419 000
04046955639069 K210419 000

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