
Guidant Corp.
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FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 is an FDA 510(k)-cleared medical device (K061865) manufactured by Guidant Corp.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 2006. Regulation: 8.