
Medtronic Vascular
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CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R is an FDA 510(k)-cleared medical device (K061127) 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 May 22, 2006. Regulation: 8.