
Terumo Medical Corp.
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DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH is an FDA 510(k)-cleared medical device (K080415) 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 March 6, 2008. Regulation: 8.