MEDCOMP ULTRA-FLOW CATHETER

MEDCOMP ULTRA-FLOW CATHETER is an FDA 510(k)-cleared medical device (K003207) manufactured by Medical Components, Inc.. 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 June 11, 2001. Regulation: 8.