12F Tri-Flow Triple Lumen Catheter

12F Tri-Flow Triple Lumen Catheter is an FDA 510(k)-cleared medical device (K181175) manufactured by Medical Components, Inc. (dba MedComp). 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 July 4, 2018. Regulation: 8.