TEMPORARY PERVENOUS J-ATRIAL LEAD

TEMPORARY PERVENOUS J-ATRIAL LEAD is an FDA 510(k)-cleared medical device (K812781) manufactured by Cordis Corp.. 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 28, 1981. Regulation: 8.