SWAN-GANZ & EDSLAB HEPARIN COATED CATH.

SWAN-GANZ & EDSLAB HEPARIN COATED CATH. is an FDA 510(k)-cleared medical device (K812563) 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 September 24, 1981. Regulation: 8.