VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF)— 510(k) K131046

Name: FDA 510(k) clearance K131046
Creator: U.S. Food and Drug Administration
Published: 2013-07-18

Substantially Equivalent

Venous Health Systems, Inc.

FDA 510(k) clearance K131046 for VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF), Substantially Equivalent on 2013-07-18. Applicant: Venous Health Systems, Inc.. Device class: 2.

Clearance details

Applicant: Venous Health Systems, Inc.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2013-04-15
Decision date: 2013-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portola Valley, CA, US

Download summary PDF View on FDA.gov ↗

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