CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT

CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT is an FDA 510(k)-cleared medical device (K040252) manufactured by Rex Medical. 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 25, 2004. Regulation: 8.