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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K151936
Device Name Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle
Applicant
Synaptic Medical Limited
Bldg. C, 100 Kechuang 6th St., Beijing Eco-Tech.
Development Area
Beijing,  CN 101111
Applicant Contact Yang Tiecheng
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/14/2015
Decision Date 12/04/2015
Decision Substantially Equivalent - Kit (SESK)
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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