
Health Line International Corporation
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Power Acute Triple Lumen Hemodialysis Catheter is an FDA 510(k)-cleared medical device (K222170) manufactured by Health Line International 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 12, 2023. Regulation: 8.