SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH

SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH is an FDA 510(k)-cleared medical device (K822350) manufactured by American Edwards Laboratories. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 23, 1982. Regulation: 8.