FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors is an FDA 510(k)-cleared medical device (K242909) 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 March 20, 2025. Regulation: 8.