VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F— 510(k) K122609

Name: FDA 510(k) clearance K122609
Creator: U.S. Food and Drug Administration
Published: 2012-12-21

Substantially Equivalent

Venous Health Systems, Inc.

FDA 510(k) clearance K122609 for VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F, Substantially Equivalent on 2012-12-21. 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: 2012-08-27
Decision date: 2012-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portola Valley, CA, US

Download summary PDF View on FDA.gov ↗

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