MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M

MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M is an FDA 510(k)-cleared medical device (K984435) manufactured by Medtronic Vascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 6, 1999. Regulation: 8.