
Fresenius Hemotechnology, Inc.
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FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW is an FDA 510(k)-cleared medical device (K012178) manufactured by Fresenius Hemotechnology, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 22, 2001. Regulation: 8.