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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 K212626
Device Name PathBuilder Transseptal Guiding Introducer
Applicant
Shanghai Microport EP Medtech Co., Ltd.
Bldg. 23&28, Lane 588, Tianxiong Rd.
Shanghai,  CN
Applicant Contact Tian Xia
Correspondent
Shanghai Microport EP Medtech Co., Ltd.
Bldg. 23&28, Lane 588, Tianxiong Rd.
Shanghai,  CN
Correspondent Contact Tian Xia
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/18/2021
Decision Date 03/23/2022
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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