DCwire® Micro Guidewire + FDA

DCwire® Micro Guidewire Receives FDA 510(k) Clearance, Marking a Key Milestone in Peijia Medical’s Global Expansion

March 18, 2026
9:09 am

SUZHOU, China, March 18, 2026 /PRNewswire/ -- Peijia Medical (9996.HK), a leading Chinese domestic company in the high-growth transcatheter valve therapeutics and neurovascular interventions markets, announced that its DCwire® Micro Guidewire has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") on March 17, 2026. The product was independently designed and developed by Achieva Medical Limited, a subsidiary of the Company.

This milestone represents the first FDA-cleared product in the Company’s portfolio and underscores Peijia Medical’s continued commitment to innovation in the field of neurointerventional medical devices. The clearance also marks a significant step forward in the Company’s global expansion strategy, enabling its entry into the U.S. market.

“We are delighted to achieve this important milestone with the FDA clearance of DCwire^®,” said Dr. Yi Zhang, Chairman and CEO of Peijia Medical. “This accomplishment not only validates our product development capabilities but also lays a strong foundation for the international commercialization of our neurointerventional portfolio.”

DCwire® Micro Guidewire Receives FDA 510(k) Clearance, Marking a Key Milestone in Peijia Medical’s Global Expansion

Sign up for Blog Updates