
Merit Medical Systems, Inc.
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Elation Pulmonary Balloon Dilation is an FDA 510(k)-cleared medical device (K161392) manufactured by Merit Medical Systems, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 31, 2016. Regulation: 8.

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SKU VM-1270031