BIOGUARD INFUSION LINE FILTER

BIOGUARD INFUSION LINE FILTER is an FDA 510(k)-cleared medical device (K791822) manufactured by United States Surgical, A Division of Tyco Healthc. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 12, 1979. Regulation: 8.