14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL

14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL is an FDA 510(k)-cleared medical device (K020315) 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 May 23, 2002. Regulation: 8.