What helps Innomed's product to enter the US market?
Recently Suzhou Innomed Medical Device Co. Ltd. (Innomed) received a 510(k) Premarket Notification (K172187) from the US FDA for its interventional high-end consumable material, Inno-Hydrowire. This implies that Innomed has the ability to produce internationally competitive products and has a positive effect on the company’s efforts to explore overseas market.
The following four features of Inno-Hydrowire enabled it to enter the international market:
It is made of nickel-titanium alloy wire and has excellent torque response and holding power.
Its surface is coated with a layer of hydrophilic coating that features high stability, increasing lubricity of the guidewire.
It has excellent development effect and enables accurate positioning in the X-ray equipment.
Guidewire of 0.018inch and below can reach tiny blood vessels.
Comparison diagram between Inno-Hydrowire and its rivals
This is Innomed’s first product available in the market. Registration with China Food and Drug Administration (CFDA) is almost complete.
Dr. Gong Xiaoyan, Chairman of Innomed
“This day marks an important milestone for Innomed. Obtaining the 510(k) Premarket Notification means that this product has been approved to enter the US market. This is a good starting point for Innomed’s products to be officially launched into the international market.”