INTRAMAX ITI GUIDE CATHETER

INTRAMAX ITI GUIDE CATHETER is an FDA 510(k)-cleared medical device (K992622) manufactured by Intratherapeutics, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 28, 1999. Regulation: 8.