DiamondTOUCH Inflation Device and Fluid Dispensing Syringe

DiamondTOUCH Inflation Device and Fluid Dispensing Syringe is an FDA 510(k)-cleared medical device (K160107) manufactured by Merit Medical Systems, 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 July 28, 2016. Regulation: 8.