
Medamicus, Inc.
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PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 is an FDA 510(k)-cleared medical device (K013120) manufactured by Medamicus, Inc.. 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 23, 2002. Regulation: 8.