HeartCare Medical-B (06609.HK): SupSelek™ Microcatheter Receives FDA 510(k) Clearance

HeartCare-B(06609) announced that the U.S. Food and Drug Administration (FDA) has recently granted 510(k) clearance for the company's SupSelek™ microcatheter under the Food, Drug and Cosmetic Act.

As of the date of this announcement, the company has obtained FDA 510(k) clearance for two products: the SupSelek™ microcatheter and the Fullblock™ occlusion balloon catheter. The company will continue to apply for approvals and registrations for its products overseas.

The Company cannot guarantee that it will be successful in marketing and/or commercializing the SupSelek™ microcatheter or Fullblock™ occlusion balloon catheter.