
Medtronic Vascular
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CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 is an FDA 510(k)-cleared medical device (K070311) manufactured by Medtronic Vascular. 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 April 23, 2007. Regulation: 8.