510(k) K964238

AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS by Aircast, Inc. — Product Code JOW

K964238 is an FDA 510(k) premarket notification submitted by Aircast, Inc. for the device "AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS". The FDA issued a decision of Substantially Equivalent on September 8, 1997. 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.