SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH

SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH is an FDA 510(k)-cleared medical device (K880482) 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 March 17, 1988. Regulation: 8.