SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)

SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM) is an FDA 510(k)-cleared medical device (K910204) 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 April 23, 1991. Regulation: 8.