Cleared Traditional

AMADEUS ADAPTIVE COMPRESSION THERAPY

K071763 · Convatec · Cardiovascular
Mar 2008
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K071763 is an FDA 510(k) clearance for the AMADEUS ADAPTIVE COMPRESSION THERAPY, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Convatec (Skillman, US). The FDA issued a Cleared decision on March 7, 2008, 252 days after receiving the submission on June 29, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K071763 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2007
Decision Date March 07, 2008
Days to Decision 252 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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