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Vascular Control Systems, Inc.
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CSTAT, MODELS 09-0014-01 AND 09-0014-02 is an FDA 510(k)-cleared medical device (K032125) manufactured by Vascular Control Systems, 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 February 8, 2004. Regulation: 8.