
Rex Medical, L.P.
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CLEANER ROTATIONAL THROMBECTOMY SYSTEM is an FDA 510(k)-cleared medical device (K060904) manufactured by Rex Medical, L.P.. 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 27, 2006. Regulation: 8.