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Possis Medical, Inc.
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ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS is an FDA 510(k)-cleared medical device (K072769) manufactured by Possis Medical, 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 November 13, 2007. Regulation: 8.