WellsForm Tricuspid Annuloplasty Band (WF)

WellsForm Tricuspid Annuloplasty Band (WF) is an FDA 510(k)-cleared medical device (K230679) manufactured by Genesee Biomedical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 25, 2023. Regulation: 8.