POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333

POLYFIN WITH WINGS INFUSION SETS, MODELS 306, 307, 333 is an FDA 510(k)-cleared medical device (K964455) manufactured by Medtronic Minimed. 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 January 29, 1997. Regulation: 8.