INTHERM TEMPORARY OCCLUSION CATHETER

INTHERM TEMPORARY OCCLUSION CATHETER is an FDA 510(k)-cleared medical device (K901287) 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 February 19, 1991. Regulation: 8.