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Medtronic, Ireland
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ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM is an FDA 510(k)-cleared medical device (K053431) manufactured by Medtronic, Ireland. 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 15, 2006. Regulation: 8.