SHANGHAI HEARTCARE MEDICAL TECHNOLOGY CORPORATION LIMITED Shanghai HeartCare Medical Technology Corporation Limited announced that the Food and Drug Administration of the United States of America has granted section 510k clearance pursuant to the Food, Drug and Cosmetic Act in relation to the company's SupSelekTM Microcatheter. As of the date of this announcement, the company has obtained section 510k clearance from the FDA on two products, including SupSelekTM Microcatheter and FullblockTM Balloon Guiding Catheter. The company will continue to pursue clearances and registrations of its products abroad.
There is no assurance that either SupSelekTM Microcatheter or FullblockTM Balloon Guiding Catheter will ultimately be successfully marketed and/or commercialized by the Company.
