Merits hydrophilic guidewire earns FDA 510(k) clearance

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Merit Medical Systems, a manufacturer of disposable medical devices used in interventional and diagnostic procedures, has received 510(k) clearance from the FDA for the Merit Laureate.

The Merit Laureate guidewire is fabricated from a core Nitinol wire, covered with a urethane jacket and coated with a process that produces a slippery surface, according to the South Jordan, Utah-based company. Features of the wire, including torquability and pushability, allow passage through tortuous anatomy.

The guidewire is slated for global release in January 2010.