NEW YORK (Thomson Financial) - Merit Medical Systems Inc. Thursday received
notification from the Food and Drug Administration of 510(k) clearance for its
new Sea Dragon torque device.
A 510(k) is a premarket submission that must be filed with the FDA by anyone
who wants to market a device intended for human use.
The Sea Dragon torque device is used with hydrophilic guide wires and has
been well-received by physicians in Europe, where it was recently released,
Merit Medical said.
Merit is a South Jordan, Utah-based manufacturer of disposable medical
products used in the diagnosis and treatment of cardiovascular disease. Its
stock was up 1.1% at $15.22.
Melinda Peer
mp/jw
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