Business
DCwire® Micro Guidewire Receives FDA 510(k) Clearance, Marking a Key Milestone in Peijia Medical's Global Expansion
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.
About this update from Peijia Medical Ltd.
[{"type":"text","content":"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.","length":467,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/Peijia Medical)","displaySize":"","headline":null,"caption":"(PRNewsfoto/Peijia Medical)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":225,"url":"https://media.zenfs.com/en/prnewswire.com/e378995a692ee57ba72652d9104b47a3"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/pHSM1YpXq0qVN5y.SIsBsw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTM5NztjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/e378995a692ee57ba72652d9104b47a3","width":400,"height":225}},"href":"https://mma.prnewswire.com/media/2166853/PEIJIA_Logo_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"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.","length":352,"tagName":"p"},{"type":"text","content":""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."","length":354,"tagName":"p"},{"type":"text","content":"Peijia Medical remains committed to delivering high-quality, innovative medical technologies to patients worldwide and will continue to strengthen its presence in key international markets.","length":189,"tagName":"p"},{"type":"text","content":"About the Company","length":17,"tagName":"p"},{"type":"text","content":"Peijia Medical (9996.HK) was established in 2012 and is headquartered in Suz...