Merit Medical gains 510(k) clearance for three products:
This article was originally published in Clinica
South Jordan, Utah firm Merit Medical has received notification from the FDA of 510(k) clearance for three of its products. The first is its Resolve biliary catheter. The device is placed into the common bile duct, the vessel through which bile flows from the gallbladder and the liver to the small intestine. The Resolve catheter drains the bile either internally - inside the intestines - or externally - into a bag outside the body. The All-Star haemostasis valve and the Prelude marker tip introducer sheath have also been cleared for sale. The All-Star valve is designed to maintain a fluid-tight seal around interventional devices and to reduce patient blood loss. And the Prelude introducer sheath allows visualisation of the sheath tip for precise placement during interventional and diagnostic procedures.
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