
Fresenius Medical Care North America
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CRIT-LINE CLIP (CLIC) BLOOD CHAMBER is an FDA 510(k)-cleared medical device (K152953) manufactured by Fresenius Medical Care North America. 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 November 4, 2015. Regulation: 8.