
Guidant Corporation, Cardiac Surgery
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HEARTSTRING III PROXIMAL SEAL SYSTEM is an FDA 510(k)-cleared medical device (K080169) manufactured by Guidant Corporation, Cardiac Surgery. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 7, 2008. Regulation: 8.