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Guidant Corp.
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GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500 is an FDA 510(k)-cleared medical device (K022880) manufactured by Guidant Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 12, 2002. Regulation: 8.