AIRCAST VENAFLOW SYSTEM (MODIFICATION)

AIRCAST VENAFLOW SYSTEM (MODIFICATION) is an FDA 510(k)-cleared medical device (K961676) manufactured by Aircast, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 27, 1997. Regulation: 8.