Merits hydrophilic guidewire earns FDA 510(k) clearance
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.
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.