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Medtronic Surgical Navigation Technologies
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CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM is an FDA 510(k)-cleared medical device (K022126) manufactured by Medtronic Surgical Navigation Technologies. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 2, 2003. Regulation: 8.