
Fresenius Medical Care
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CRIT-LINE IV SYSTEM is an FDA 510(k)-cleared medical device (K141997) manufactured by Fresenius Medical Care. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 31, 2015. Regulation: 8.