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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K180389
Device Name Venera 508 Deep Vein Thrombosis (DVT) Prevention System
Applicant
Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
#789, Wu Fang Rd., Friendship Industrial Zone,
Song Ling Town, Wu Jiang
Suzhou,  CN 215222
Applicant Contact Michael Ying
Correspondent
Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
#789, Wu Fang Rd., Friendship Industrial Zone,
Song Ling Town, Wu Jiang
Suzhou,  CN 215222
Correspondent Contact Alex Wang
Regulation Number870.5800
Classification Product Code
JOW  
Date Received02/13/2018
Decision Date 06/29/2018
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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