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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous flush
510(k) Number K212719
Device Name Micro Catheter and Guidewire System
Applicant
Suzhou Hengrui Hongyuan Medical Co., Ltd
Building B9 Unit 201, No. 218 Xinghu Road, SIP
Suzhou,  CN 215126
Applicant Contact Wang Peipei
Correspondent
Suzhou Hengrui Hongyuan Medical Co., Ltd
Building B9 Unit 201, No. 218 Xinghu Road, SIP
Suzhou,  CN 215126
Correspondent Contact Wang Peipei
Regulation Number870.1210
Classification Product Code
KRA  
Date Received08/27/2021
Decision Date 04/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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