Cleared Traditional

REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS

K012675 · Adven Medical · Cardiovascular
Feb 2002
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K012675 is an FDA 510(k) clearance for the REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Adven Medical (Lubbock, US). The FDA issued a Cleared decision on February 12, 2002, 182 days after receiving the submission on August 14, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K012675 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2001
Decision Date February 12, 2002
Days to Decision 182 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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