SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER

SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER is an FDA 510(k)-cleared medical device (K905458) manufactured by Baxter Healthcare Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 1991. Regulation: 8.