
Cook Vascular, Inc.
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EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 is an FDA 510(k)-cleared medical device (K061000) manufactured by Cook Vascular, 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 May 9, 2006. Regulation: 8.