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Pendracare International, B.V.
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CONVEY GUIDING CATHETER is an FDA 510(k)-cleared medical device (K120585) manufactured by Pendracare International, B.V.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 7, 2012. Regulation: 8.