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Aga Medical Corp.
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AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 is an FDA 510(k)-cleared medical device (K071125) manufactured by Aga Medical 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 June 17, 2007. Regulation: 8.