
Terumo Medical Corp.
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PINNACLE R/O II OR RADIFOCUS INTRODUCER II is an FDA 510(k)-cleared medical device (K003424) manufactured by Terumo Medical Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 20, 2000. Regulation: 8.