SWAN-GANZ VIP-CATHETER

SWAN-GANZ VIP-CATHETER is an FDA 510(k)-cleared medical device (K820222) 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 February 11, 1982. Regulation: 8.