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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K150932
Device Name Sheath Introducer
Applicant
Bioteque Corp.
5 F-6, # 23, Sec. 1
Chang-An E. Rd.
Taipei,  TW 104
Applicant Contact Simon Lin
Correspondent
Bioteque Corp.
5 F-6, # 23, Sec. 1
Chang-An E. Rd.
Taipei,  TW 104
Correspondent Contact Stella Hsu
Regulation Number870.1310
Classification Product Code
DRE  
Date Received04/06/2015
Decision Date 07/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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