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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 K103113
Device Name VASCULAIRE COMPRESSION SYSTEM
Applicant
Venous Health Systems, Inc.
155-A Moffett Park Dr.,
Suite 210
Sunnyvale,  CA  94089
Applicant Contact Albert Boniske
Correspondent
Venous Health Systems, Inc.
155-A Moffett Park Dr.,
Suite 210
Sunnyvale,  CA  94089
Correspondent Contact Albert Boniske
Regulation Number870.5800
Classification Product Code
JOW  
Date Received10/21/2010
Decision Date 02/02/2011
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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