
Catheter Robotics, Inc.
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AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES is an FDA 510(k)-cleared medical device (K122488) manufactured by Catheter Robotics, 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 November 19, 2012. Regulation: 8.