PEIJIA-B (09996) obtains first FDA 510(k) clearance for DCwire® Micro Guidewire

Bulletin Express

Mar 17

Peijia Medical Limited (PEIJIA-B, 09996) announced that its subsidiary, Achieva Medical Limited, has received 510(k) clearance from the U.S. Food and Drug Administration for the DCwire® Micro Guidewire. This marks the Group’s first U.S. regulatory approval and represents a significant milestone in its globalisation strategy.

According to the filing, DCwire® was independently designed and developed within the Group. With the FDA decision, the product is now authorised for commercialisation in the United States, subject to the company’s subsequent market-launch execution. Management emphasised that the clearance strengthens the Group’s overseas product portfolio, although it cautioned that successful commercial rollout beyond China is not guaranteed.

The voluntary announcement, released on 17 March 2026, reiterates that shareholders and prospective investors should exercise due care when trading the company’s shares. The Board is chaired by Executive Director Dr. Yi Zhang, with a total of four independent non-executive directors providing oversight.

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This marks the Group’s first U.S. regulatory approval and represents a significant milestone in its globalisation strategy.</p>\n<p>According to the filing, DCwire® was independently designed and developed within the Group. With the FDA decision, the product is now authorised for commercialisation in the United States, subject to the company’s subsequent market-launch execution. Management emphasised that the clearance strengthens the Group’s overseas product portfolio, although it cautioned that successful commercial rollout beyond China is not guaranteed.</p>\n<p>The voluntary announcement, released on 17 March 2026, reiterates that shareholders and prospective investors should exercise due care when trading the company’s shares. 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