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Medtronic Vascular
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PURPLE/BLACK HEPARIN ASSAY CONTROL is an FDA 510(k)-cleared medical device (K042206) manufactured by Medtronic Vascular. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 17, 2004. Regulation: 8.