FDA clears Laureate hydrophilic guidewire


The US Food and Drug Administration (FDA) has given 510(k) clearance to Merit Medical for its Laureate hydrophilic guidewire.

In February 2012, Merit Medical received a warning letter from the FDA regarding modifications in the manufacturing process for which the FDA required additional information. Merit complied by filing a new 510(k) submission.

“We are pleased to conclude this process and provide this product immediately to our US customers,” said Fred P Lampropoulos, Merit Medical’s chairman and CEO. “We believe this segment of the guidewire business offers substantial opportunity and intend to introduce additional hydrophilic wires upon regulatory clearance in the near future.”

(Visited 28 times, 1 visits today)