14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55

14F X 55CM ULTRA-FLOW CATHETER, MODELS UFS55, UFT55 is an FDA 510(k)-cleared medical device (K021759) 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 August 26, 2002. Regulation: 8.