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Abbott Vascular-Vascular Solutions
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MODIFICATION TO: FOX PLUS PTA CATHETER is an FDA 510(k)-cleared medical device (K080264) manufactured by Abbott Vascular-Vascular Solutions. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 25, 2008. Regulation: 8.