VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F


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

Correspodent Contact rich laguna
Regulation Number 870.5800
Classification Product Code
JOW  
Date Received 08/27/2012
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