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510(k) K210419

BIOTEQ Drainage Catheter BT-PDS-series by Bioteque Corporation — Product Code FGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2022
Date Received
February 11, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

Other clearances by Bioteque Corporation

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  • K200103 — BIOTEQ Drainage Catheter Set (One Step Type) (October 9, 2020)

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