Cleared Traditional

ARTERIALFLOW SYSTEM, MODEL 32A

K024019 · Aircast, Inc. · Cardiovascular
Jun 2003
Decision
180d
Days
Class 2
Risk

About This 510(k) Submission

K024019 is an FDA 510(k) clearance for the ARTERIALFLOW SYSTEM, MODEL 32A, a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Aircast, Inc. (Summit, US). The FDA issued a Cleared decision on June 3, 2003, 180 days after receiving the submission on December 5, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K024019 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2002
Decision Date June 03, 2003
Days to Decision 180 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

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

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