Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K131046 |
Device Name |
VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF) |
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 | 04/15/2013 |
Decision Date | 07/18/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|