Cleared Traditional

K023800 - VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017
(FDA 510(k) Clearance)

K023800 · Aircast, Inc. · Cardiovascular device

Feb 2003

Decision

88d

Days

Class 2

Risk

K023800 is an FDA 510(k) clearance for the VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).

Submitted by Aircast, Inc. (Summit, US). The FDA issued a Cleared decision on February 10, 2003, 88 days after receiving the submission on November 14, 2002.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.

Submission Details

510(k) Number	K023800 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 14, 2002
Decision Date	February 10, 2003
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement