INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM

INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM is an FDA 510(k)-cleared medical device (K922970) manufactured by Intensive Technology, 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 January 12, 1993. Regulation: 8.