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Biosense Webster, Inc.
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CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 is an FDA 510(k)-cleared medical device (K080425) manufactured by Biosense Webster, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 22, 2008. Regulation: 8.