
Navion Biomedical Corp.
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1.4 FR MAPCATH SENSOR STYLET is an FDA 510(k)-cleared medical device (K973057) manufactured by Navion Biomedical Corp.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 11, 1997. Regulation: 8.

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