Novalung ultimate kit (US)

Novalung ultimate kit (US) is an FDA 510(k)-cleared medical device (K232926) manufactured by Fresenius Medical Care Renal Therapies Group, 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 April 14, 2024. Regulation: 8.