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Abbott Vascular-Vascular Solutions
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EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19 is an FDA 510(k)-cleared medical device (K090665) 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 May 21, 2009. Regulation: 8.