
Medtronic Vascular
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SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74 is an FDA 510(k)-cleared medical device (K061416) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 24, 2006. Regulation: 8.