HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER

HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER is an FDA 510(k)-cleared medical device (K033294) manufactured by C.R. Bard, 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 November 25, 2003. Regulation: 8.