
Estech, Inc.
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REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA is an FDA 510(k)-cleared medical device (K052081) manufactured by Estech, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2005. Regulation: 8.

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