Cleared Traditional

AIRCAST VENAFLOW SYSTEM (MODIFICATION)

K961676 · Aircast, Inc. · Cardiovascular
Mar 1997
Decision
350d
Days
Class 2
Risk

About This 510(k) Submission

K961676 is an FDA 510(k) clearance for the AIRCAST VENAFLOW SYSTEM (MODIFICATION), a Sleeve, Limb, Compressible (Class II — Special Controls, product code JOW), submitted by Aircast, Inc. (Summit, US). The FDA issued a Cleared decision on March 28, 1997, 350 days after receiving the submission on April 12, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number K961676 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1996
Decision Date March 28, 1997
Days to Decision 350 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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