ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65

ITI INTRAMAX GUIDE CATHETER 91, 78 AND 65 is an FDA 510(k)-cleared medical device (K981191) 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 April 6, 1999. Regulation: 8.