
Baxter Healthcare Corporation
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Revaclear 500, Revaclear 400, Revaclear 300 is an FDA 510(k)-cleared medical device (K213639) manufactured by Baxter Healthcare Corporation. 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 January 23, 2022. Regulation: 8.