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Hansen Medical, Inc.
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HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH is an FDA 510(k)-cleared medical device (K052480) manufactured by Hansen Medical, 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 1, 2007. Regulation: 8.
