510(k) K023800

VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017 by Aircast, Inc. — Product Code JOW

K023800 is an FDA 510(k) premarket notification submitted by Aircast, Inc. for the device "VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017". The FDA issued a decision of Substantially Equivalent on February 10, 2003. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Aircast, Inc. has at least 10 other 510(k) clearances on record.