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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 K122609
Device Name VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F
Applicant
Venous Health Systems, Inc.
3270 Alpine Rd.
Portola Valley,  CA  94028
Applicant Contact RICH LAGUNA
Correspondent
Venous Health Systems, Inc.
3270 Alpine Rd.
Portola Valley,  CA  94028
Correspondent Contact RICH LAGUNA
Regulation Number870.5800
Classification Product Code
JOW  
Date Received08/27/2012
Decision Date 12/21/2012
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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