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.”