
St Jude Medical
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REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804 is an FDA 510(k)-cleared medical device (K062251) manufactured by St Jude Medical. 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 19, 2006. Regulation: 8.