FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band

FlexForm Annuloplasty Ring and FlexForm Annuloplasty Band is an FDA 510(k)-cleared medical device (K161815) 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 October 11, 2016. Regulation: 8.