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Medtronic Ablation Frontiers, LLC
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ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE is an FDA 510(k)-cleared medical device (K102588) manufactured by Medtronic Ablation Frontiers, LLC. 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 17, 2011. Regulation: 8.