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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K193653
Device Name Hydrophilic Coating Guide Wire
Applicant
Suzhou Hengrui Disheng Medical Co., Ltd.
# 11 Bldg., #8 Jinfeng Rd.
Suzhou 215163,  CN 215163
Applicant Contact Ling Li
Correspondent
Suzhou Hengrui Disheng Medical Co., Ltd.
# 11 Bldg., #8 Jinfeng Rd.
Suzhou 215163,  CN 215163
Correspondent Contact Ling Li
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/30/2019
Decision Date 08/26/2020
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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