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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 K222184
Device Name Introducer Sheath Kits
Applicant
Beijing Demax Medical Technology Co.,Ltd
101, Floor 1-3, 13-7a Jingshengnansi St., Beijing
Economic-Technological Development Area
Beijing,  CN 101102
Applicant Contact Anny Zhang
Correspondent
Guangzhou Osmunda Medical Device Consulting Co., Ltd.
9th Floor, R&D Bldg., # 26 Qinglan St.
Panyu District
Guangzhou,  CN 510006
Correspondent Contact Olivia Meng
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/22/2022
Decision Date 02/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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