MEDCOMP SPLIT-CATH II

MEDCOMP SPLIT-CATH II is an FDA 510(k)-cleared medical device (K040318) manufactured by 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 February 2, 2005. Regulation: 8.