ITC CATHETERS W/ HYDROMER

ITC CATHETERS W/ HYDROMER is an FDA 510(k)-cleared medical device (K922609) manufactured by Interventional Therapeutics Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 29, 1993. Regulation: 8.