OPUS MODEL 4021, VVI, 5MM UNIPOLAR

OPUS MODEL 4021, VVI, 5MM UNIPOLAR is an FDA 510(k)-cleared medical device (K900461) manufactured by Ela Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on March 13, 1990. Regulation: 8.