Sheath Introducer

Dilator, Vessel, For Percutaneous Catheterization

BIOTEQUE CORP.

The following data is part of a premarket notification filed by Bioteque Corp. with the FDA for Sheath Introducer.

Pre-market Notification Details

Device IDK150932
510k NumberK150932
Device Name:Sheath Introducer
ClassificationDilator, Vessel, For Percutaneous Catheterization
Applicant BIOTEQUE CORP. 5 F-6, NO. 23, SEC. 1 CHANG-AN E. ROAD Taipei,  TW 104
ContactSimon Lin
CorrespondentStella Hsu
BIOTEQUE CORP. 5 F-6, NO. 23, SEC. 1 CHANG-AN E. ROAD Taipei,  TW 104
Product CodeDRE  
CFR Regulation Number870.1310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-06
Decision Date2016-07-22
Summary:summary

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