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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 K201720
Device Name LiPPS Analyzer, LiPPS Wire Pressure Guide Wire
Applicant
Beijing Bywave Sensing Medical Technology Co., Ltd.
Rm. 501, Buildinctg 22, #12, Juyuan Middle Rd.,
Mapo Town, Shunyi District
Beijing,  CN 101399
Applicant Contact Lizhe Zhang
Correspondent
Beijing Bywave Sensing Medical Technology Co., Ltd.
Rm. 501, Buildinctg 22, #12, Juyuan Middle Rd.,
Mapo Town, Shunyi District
Beijing,  CN 101399
Correspondent Contact Lizhe Zhang
Regulation Number870.1330
Classification Product Code
DQX  
Subsequent Product Code
DXO  
Date Received06/23/2020
Decision Date 02/18/2021
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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