ENCOR UNIPOLAR VS-1 LEADS

ENCOR UNIPOLAR VS-1 LEADS is an FDA 510(k)-cleared medical device (K883070) manufactured by Cordis Leads, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on December 4, 1988. Regulation: 8.