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Cardiac Assist, Maquet Cardiovascular, LLC
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SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES is an FDA 510(k)-cleared medical device (K112327) manufactured by Cardiac Assist, Maquet Cardiovascular, 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 September 8, 2011. Regulation: 8.