Cleared Traditional

REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP

K021528 · Adven Medical · Cardiovascular
Aug 2002
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K021528 is an FDA 510(k) clearance for the REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Adven Medical (Lubbock, US). The FDA issued a Cleared decision on August 21, 2002, 103 days after receiving the submission on May 10, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K021528 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2002
Decision Date August 21, 2002
Days to Decision 103 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code JOW — Sleeve, Limb, Compressible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5800

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