NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER

NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER is an FDA 510(k)-cleared medical device (K113227) manufactured by Baxter Healthcare Corp. 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 December 7, 2011. Regulation: 8.