Acute Dual Lumen Hemodialysis Catheter

Acute Dual Lumen Hemodialysis Catheter is an FDA 510(k)-cleared medical device (K200426) 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 December 23, 2020. Regulation: 8.