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Medtronic Percusurge, Inc.
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MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM is an FDA 510(k)-cleared medical device (K014223) manufactured by Medtronic Percusurge, 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 January 24, 2002. Regulation: 8.