
Coeur, Inc.
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ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS is an FDA 510(k)-cleared medical device (K070798) manufactured by Coeur, 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 October 3, 2007. Regulation: 8.