EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER

EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER is an FDA 510(k)-cleared medical device (K110103) manufactured by Edwards Lifesciences, LLC. 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 10, 2011. Regulation: 8.