GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY

GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY is an FDA 510(k)-cleared medical device (K903840) manufactured by Intec Medical, 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 October 15, 1990. Regulation: 8.