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 Number | 870.5800
|
Classification Product Code |
|
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
|
|
|